FEASIBILITY, ACCEPTABILITY , AND USABILITY OF A MOBI LI Z ED PSYCHOEDUCATION AND SKILLS BASED INTERVENTION (PEP PAL) TO HELP CAREGIVERS OF PATIENTS WITH ADVANCE D CANCER by ALAINA L EA CARR B . A . , University of Colorado , 2014 A thesis submitted to the Faculty of the Graduate School of the University of Colorado in partial fulfilment of the requirements for the degree of Master of Arts Psychology 2018
ii This thesis for the Master of Arts degree by Alaina Lea Carr Has been approved for the Psychology Program B y Kristin Kilbourn, Chair Jim Grigsby Nicole Amoyal Pensak Jaqueline Jones Date: May 22 nd , 2018
iii Carr, Alaina Lea (M. A . , Psychology Program) Feasibility, Acceptability, and Usability of a Mobilized Psychoeducation and Skills Based Intervention (Pep Pal) to Help Caregivers of Patients with Advanced Cancer Thesis directed by Associate Professor Kristin Kilbourn ABSTRACT Background: Caregivers of patients w ith advanced diseases are a highly distressed population. Recent research has focused on recognizing caregivers in need of psychosocial support to help them manage their distress. In addition, there has been advocacy for the use of technology to provide su pport to caregivers given their many barriers to engaging in self care activities . The current study aim ed to examine feasibility, acceptability and usability of the Pep Pal intervention using a mixed methods approach . Caregivers of patients with advanced cancer were recruited from one of three settings at an academic medical center ; the hematopoietic stem cell transplants ( HSCT ) unit , the phase I oncology trials clinic , and the hematolo gy/oncology clinic . This study explored the feasibility, acceptability, and usability of Pep Pal for caregivers who may benefit from an evidenced based technological intervention aimed to aid caregivers in managing their distress . Methods: This study wa s a sub study of a larger funded project , a randomized pilot control trial of a m obilized psyc hoeducation and skills b ased i ntervention (Pep Pa l ) for caregivers of advanced i llness . The larger project examined the effects of the intervention on anxiety, depression, stress, and quality of life compar ed to those in the control group who receive d treatment as usual. Th e larger Pep Pal p roject recruited 60 caregivers who were randomly assigned to the Pep Pal intervention or a treatment as usual condition . The current
iv sub study utilize d mixed methods analysis from select quantitative data from the 26 intervention participants and qualitative data from the first eight caregiver participants , which assess ed feasibility, acceptability , and usability of the Pep Pal program . Additionally, the first eight caregivers who complete d the Pep Pal intervention participate d in a 60 90 minute semi structured individual interviews , which assess ed the helpfulness and utility of the Pep Pal program within the first four weeks intervention completion . Applied thematic analysis was conducted via the independent review of transcripts using Atlas.ti, a qualitative analysis software , to extract salient themes. Results: Eight five percent of eligible caregivers enrolled in the Pep Pal program. However, only 27 . 7 % of intervention caregivers completed at or above seven out of nine full length sessions. Intervention participants found all Pep Pal intervention sessions except for the Improving Intimacy session to be acceptable. When qu alitative ly assessed, the topic of the physical intimacy instead of the content of the session provided rationale for reduced acceptability ratings of the session. Overall, intervention participants agreed with the usability of the web based platform during their experience in the intervention . Conclusion: This mixed methods study demonstrated that the Pep Pal intervention is feasible in recruitment, acceptable in the majority of intervention sessions , and the program was able to successfully establish usability criteria for the perceived experience of usability in the web based platform . Recommendations for adaptions to the intervention such as a mobile app lication for smartphone utilization of the intervention are explored. Future studies of the Pep Pal program are needed to establish beneficial effects of the Pep Pal intervention in reducing anxiety, depression, stress, sexual dysfunction and improving quality of life. Keywords: Caregivers, M obilized psychosocial intervention, RCT, D istress
v The form and content of this abstract are approved. I recommend its publication. Approved: Kristin Kilbourn
vi TABLE OF CONTENTS CHAPTER I. INTRODUCTION ................................ ................................ ................................ ................ 1 Caregiver related Stressors ................................ ................................ ................................ . 1 Caregiver Distress ................................ ................................ ................................ ............... 2 Distress specific to hematopoietic stem cell transplant caregivers. ........................ 3 Distress specific to caregivers of phase I trial cancer patients. ............................... 4 Distress specific to caregivers of advance cancer patients. ................................ .... 5 Caregiver Self care ................................ ................................ ................................ ............. 5 Research Examining Caregiver Interventions ................................ ................................ .... 6 Use of technology in psychosocial interventions ................................ ................................ 9 The PsychoEducation and Paced Respiration and Relaxation (PEPRR) P rogram ........... 11 II. METHODS ................................ ................................ ................................ ........................ 12 Purpose and Specific Aims of the Current Study ................................ ............................. 12 Table 1. ................................ ................................ ................................ ................. 14 Table 2. ................................ ................................ ................................ ................. 14 Participants ................................ ................................ ................................ ........................ 17 Procedures ................................ ................................ ................................ ......................... 17 Data collection measures ................................ ................................ ................................ .. 18 Demographic questionnaire. ................................ ................................ ................. 18 Pep Pal usability questionnaire. ................................ ................................ ............ 19
vii Helpfulness of intervention sessions questionnaire. ................................ ............. 19 Semi structured interview. ................................ ................................ .................... 19 Data analysis ................................ ................................ ................................ ..................... 20 III. RESULTS ................................ ................................ ................................ ......................... 21 Feasibility of the Pep Pal Intervention ................................ ................................ ............. 21 Figure 1. ................................ ................................ ................................ ................ 22 Study Flow Chart ................................ ................................ ................................ .. 22 Table 3. Dem ographics and key characteristics at baseline by group (N= 72) ..... 23 Acceptability of the Pep Pal intervention ................................ ................................ ......... 24 Table 4. Helpfulness of Intervention Sessions Questionnaire and sessions viewed ................................ ................................ ................................ ............................... 28 Usability of the Pep Pal Intervention ................................ ................................ ................ 28 Table 5. Pep Pal Usability Questionnaire ................................ ............................. 30 IV. DISCUSSION ................................ ................................ ................................ ................... 30 Limitations ................................ ................................ ................................ ........................ 36 Conclusions, Implications and Future Directions ................................ ............................. 38 REFERENCES ................................ ................................ ................................ ....................... 40 APPENDIX A . Pep Pal Full Length Sessions ................................ ................................ ........................... 44 B . Mini Pep Pal Sessions ................................ ................................ ................................ ........ 46 C . C onsort Diagram ................................ ................................ ................................ ................ 47
viii D . Caregiver Demographics Questionnaire ................................ ................................ ............ 48 E . Pep Pal Usability Questionnaire ................................ ................................ ......................... 53 F . Semi Structured Interview Guide . ................................ ................................ ...................... 56
1 CHAPTER I INTRODUCTION Caregiver related S tressors There are over 40 million informal caregivers in the United States (Feinberg, Reinhard, Houser, & Choula, 2011) and the number of caregivers will continue to in crease over time as the baby boomers continue to age (Reinhard, Feinberg, Choula, & Houser, 2015) . According to the National Study of Caregiving (NSOC), a primary informal caregiver can be defined as an individual who help s a patient with self care, mobility, or household activities (the latter, for health or functioning related reasons) and are either related to t he patient or are unrelated non paid helpers (Kasper, Freedm an, & Spillman, 2013) . F amily members often assume the role of caregiver with little to no preparation (L. Northouse, Williams, Given, & McCorkle, 2012) . These family c aregivers often aid with daily living activities (ADLs) such as phys ically demanding nursing tasks including bathing, dressing, bandaging and wound care, and managing catheters (Reinhard et al., 2015) . Additionally , family caregivers assist with instrumental activities of daily life (IADLs) such as managing bills and insurance claims and admini stering medications. Caregiving roles may vary from tangible and emotional support , such as providing companionship and helping with household tasks administering medications, to extensive physical support and medical care which can include bathing and dressing, bandaging and wound care and managing catheters . Over time, the demand and complexity of these various tasks can be overwhelming and can lead to increased levels of distress and potential caregiver burnout . (Anderson et al., 2011; Feinberg et al., 2011) .
2 Caregiver D istress Family caregivers are more likely to report higher levels of distress or depression when the patient is experiencing emotional or physical distress, poor physical functioning, and/or advanced disease (Kurtz, Kurtz, Given, & Given, 2004; L. L. Northouse, Katapodi, Schafenacker, & Weiss, 2012) . A n Am erican Psychological Association family caregiving survey showed that over half of family caregivers reported feeling overwhelmed by their caregiving responsibilities (Anderson et al., 2011; Reinhard et al., 2015) . These results indicated m any family caregivers reported the following; significantly higher levels of stress than the general population, and believe d they were doing a poor to fair job at several healthy behaviors, such as managing stress (Anderson et al., 2011) . Over time, t he challen ges and stress associated with family caregiving may increase the risk for premature mortality, coronary heart disease, sleep disturbance, and stroke in caregivers (Gibson Hunt & Reinhard, 2015 ; Haley, LaMonde, Han, Burton, & Schonwetter, 2003; Perkins et al., 2013; Schulz & Beach, 1999; Stenberg, Ruland, & Miaskows ki, 2010; Thomas, Morris, & Harman, 2002) . This is of particular concern for family caregivers of cancer patients with advanced diseases since research has shown that these caregivers are typically highly distressed (El Jawahri et al., 2015; Kessler et al., 2014; Laude nslager et al., 2015; Pensak et al., 2017) . Furthermore, t he nature of cancer prognoses can lead to rapid health deterioration over a short period of time, which can amplify family caregiver distress (Kent et al., 2016; Washington, Pike, Demiris, & Oliver, 2015) . F amily caregivers of patients with advanced cancer are highly susceptible to the ramifications of physical, psychological, social, and financial burden (Pensak et al., 2017) . The following sections describe the specific types of challenges encountered by caregivers of cancer patients who are undergoing
3 hematopoietic stem cell transplant (HSCT), are rece iving treatment in the p hase 1 trials c linic , or have been diagnosed wi th advanced stage cancer. Distress s pecific to hematopoietic s tem cell transplant caregivers. Hematopoietic stem cell transplant ( HSCT ) is commonly used to treat certain types of hematological malignancies and is often the last attempt at a cure (Laudenslager et al., 2015; Wulff Burc hfield, Jagasia, & Savani, 2013) . The process of HSCT can be both physically and emotionally exhausting for both the family caregiver and the patient. During the pre transplant phase, patients and their family caregivers often move to temporary housin g close by the hospital as they prepare for the pre transplant preparation, the transplant itself, and inpatient post transplant monitoring (Wulff Burchfield et al., 2013) . Once patients are release d to the outpatient phase of the tr ansplant process, family caregivers and the patients remain in the temporary housing for frequent hospital visits with providers, laboratory work, and sometimes hospital readmission due to complications such as G raft v s host disease or GvHD . During this p eriod of the transplant process, family caregivers provide extensive emotional and physical support for their loved ones who are often confined to specific areas of the hospital in order to minimize contact with infectious agents (Wulff Bur chfield et al., 2013) . Given the intensity of care during the transplantation process, f amily c aregivers commonly experience elevated depression and anxiety . This is especially prominent during the first 100 days post transplant due to burden of care, which includes 24/7 supervision post transplant, monitor patient for any complications such as GvHD, and providing social and practical support (Laudenslager et al., 2015) .
4 Distress s pecific to c aregivers of phase I trial cancer p atients . The primary goals of Phase I trial s is to determine the acceptability of the new anticancer agents by determining the maximum tolerated dose (MTD) , limiting toxicity, and see how the body reacts to the drug and how the drug is handled in the body (Daugherty, Banik, Janish, & Ratain, 2000; Hyman et al., 2015; Moore, 2001) . Cancer patients who have failed traditional treatments and/or no other standard therapy is available are selected for Phase 1 clinical trials (Kessler et al., 2014) . Family caregivers of phas e I oncology patients may take on specific responsibilities for their loved one during p hase I trial participation that include scheduling follow up appointments , weekly clinic visits , and monitoring physical symptoms and side effects while the patient is on the clinical trial. Additional caregiver stressors during phase I trial partic i pation include evaluation to determine if the patient fulfills enrollment criteria, anticipation of drug toxicities , awaiting imaging results, enrollment in future trials, and/ or enrollment in palliative care programs or hospice as the disease progresses (Kessler et al., 2014) . In a cross sectional study assessing the distress and emotional regulation of caregivers of p hase I oncology trial patients, p hase I caregivers reported more anxiety and perceived stress than population norms, a high prevalence of depressive symptoms, and impaired emotional regulation (Kessler et al., 2014) . These findings increase the potential for caregiver burnout as well as adverse physical and emotional health consequences for both the patient and the caregiver (Kessler et al., 2014) . This study advocated for further intervention approaches tailored to the unique needs of this population (Kessler et al., 2014) .
5 D istress specific to caregivers of advance cancer p atie nts . Caring for someone who is initially diagnosed with advanced cancer or has progressed to advance cancer is associated with a number of stressors . The c are needs of advanced cancer patients is a dynamic process that is expect ed to increase overtime and can lead to emotional conflict, strain, and guilt for the caregiver (Mor, Guadagnoli, & Wool, 1987; Mystakidou, Tsilika, Parpa, Galanos, & Vlahos, 2007; Williams & McCorkle, 2011) . In prior research, caregiver distress has been shown to inc rease as the pati and as the patient approaches death (B. Given et al., 2004; Kurtz et al., 2004; Williams & McCorkle, 2011) . A decrease in the functional status i ncreases the amount of ADL, IADL , and symptom management with which the patient requires family caregiver assistance (B. Given et al., 2004) . Additional ly, family caregivers are observers of disease progress ion in their loved one without being able to alter the course of the illness , which can further perpetuate feelings of uncertainty and helplessness (B. A. Given, Given, & Kozachik, 2001; Nijboer et al., 1998) . Caregiver S elf care Family caregivers are often in need of their own medical support given that many caregivers are older and face their own chronic health conditions . Even though family caregivers typically attend regular medical visits with their loved one with cancer, their own medical needs are often overlooked by health professionals (Candy, Jones, Drake, Leurent, & King, 2011) . Addi ti onally , health providers may not always know how to provide support or resources to family caregivers and may feel that they do not have the training, time or resources to provide medical assistance to family caregivers (Candy et al., 2011) . Family c aregiver needs are not always straig htforward, and they may vary depending on a number of individual factors such as employment, health insurance, income, and relationship status to the patient . Furthermore, family caregivers may not always recognize their own medical needs or they may avoid seeking support
6 for their own needs as to not detract (Candy et al., 2011) . As a they fail to seek medical treatment for themselves despite caring for the medical needs of their loved one (Northouse & Peters Golden, 1993) . One of the direct effects of family caregiving is that it decreases the amount of time the caregiver has to attend to their own self care. This may include engagement in healthy behaviors such as maintaining a healthy diet, engaging in regular exercise, and getting good quality sleep, and a dherence to other recommended health activities such as taking medication as recommended , engaging in health monitoring activities , and attending regular medical visits. In particular, l ack of adequate sleep combined with some of the physical tasks associ ated with family caregiving can lead to increased fatigue and exhaustion . Over time , caregivers may feel so overwhelmed by their caregiver activities that their own self care becomes a low priority . Additionally, the constant demands of caregiving can imp act social and leisure activities , which can result in isolation, loneliness, and reduced life satisfaction (Haley et al., 2003; Kurtz et al., 2004; Mystakidou et al., 2007; Perkins et al., 2013; Schulz & Beach, 1999) . Subsequently, as caregivers are less attentive to their own needs , the risk of caregiver morbidity and mortality increases (Haley et al., 2003; Nijboer et al., 1998; Perkins et al., 2013; Schu lz & Beach, 1999) . Research Examining C aregiver Interventions Two separate m eta analys i s of face to face evidence based family c aregiver interventions were conducted in order to examine the effectiveness of interventions with family caregivers. Gallagher Thompson and Coon (2007) reviewed 19 psychological interventions for family caregivers caring for an older relative with a significant physi cal and/or cognitive impairment and S Ã¶ rensen, Pinquart, & Duberstein (2002) reviewed the effectiveness of 78 interventions for family
7 caregivers of older adults. T hese two studies described a number of diverse interventions that include psychoeducational skills building programs, psychotherapy counseling, and multicomponent interv en tions such as various combin ations of educational interventions, supp ort, psychotherapy, and respite aimed at improving caregiver well being and coping skills (Gallagher Thompson & Coon, 2007; SÃ¶rensen, Pinquart, & Duberstein, 2002) . Psychoeducational skills building interventions e specific illness or disorder such as dementia or cancer and teach ing caregivers specific coping skills for managing common emotional and/or behavioral problems associated with the ir loved disease (Gallagher Thompson & Coon, 2007) . These interventions have been shown to reduce caregiver distress in those caring for a loved one with dementia and improve coping skills and self efficacy for caregiver s of dementia patients (Gallagher Thompson & Coon, 2007) . Additionally , psychotherapy counseling interventions can improve the management of symptoms of psychological distress with non cancer family caregivers (Gallagher Thompson & Coon, 2007; SÃ¶rensen et al., 2002) . Psychotherapy counseling interventions may integrate different theoretical orientations an d modalities of psychotherapy. The common goal is to train caregivers in self monitoring, challenge negative thoughts and behaviors, and encouraging caregivers to engage in positive experiences (Gallagher Thompson & Coon, 2007; SÃ¶rensen et al., 2002) . Psychotherapy counseling inte r ventions have been shown to be effective in reducing caregiver burden, depression, and enhancing caregiver well being, and caregiver knowledge (SÃ¶rensen et al., 2002) . Suggestions for future evidence based interventions include incorporation of new technologies such as phone, computer, or internet , t o enhance treatment delivery (Gallagher Thompson & Coon, 2007) .
8 There are a number of studies examining interventions for informal caregivers of cancer patients (Candy et al., 2011; Kent et al., 2016; Santin, Coleman, Mills, Cardwell, & Donnelly, 2012; Thomas et al., 2002) . In particular, a meta analysis o f 29 randomized control trials ( RCTs ) o f family caregivers of cancer patients examined the characteristics of the interventions and the impact on outcomes measures which included caregiver burden, distress and anxiety, and informational needs (L. L. Northouse, Katapod i, Song, Zhang, & Mood, 2010) . Psychoeducational interventions , skills training programs , and therapeutic counseling were among the most common types of interventions. Psychoeducation and skills training w ere the most common combination of intervention strategies . The content of the 29 interventions was coded into primary three domains: p a tient caregi ving, marital and family care, and caregiver self care . Patient caregiving such as information and skills to assist caregivers perform care tasks was found in 25 (71.4%) of the intervention protocols and marital and family care including information and skills to assist caregivers with manage family or partner concerns was also found in 25 (71.4%) of the intervention protocols (L. L. Northouse et al., 2010) . Caregiver self care such as information, ski lls, and support to assist caregivers with their own physical and psychological health needs, improve self confidence, social support, and access to resources were addressed in 27 (77.1%) of the intervention protocols (L. L. Northouse et al., 2010) . However, many of these interventions were primaril y designed to assess patient care while caregiver self care was a secondary focus of intervention designs. Overall, interventions delivered to family caregivers of cancer patients exhibited a significant positive effect on several outcomes. Caregivers reported less caregiver burden, greater caregiving benefit, less informational needs, higher self efficacy, use of several effective coping strategies, increase in physical functioning, marital and family satisfaction, improve d social support, and reduced distress and anxiety. Coping , self efficacy, and distress and
9 anxiety outcomes were positive and sustained intervention effects across studies at initial, intermediate, and longitudinal assessments while caregiver benefit, ph ysical functioning, and social functioning were delayed intervention effects in studies with a 6 month follow up post intervention . These interventions targeted at caregivers of cancer patients reported small to moderate effect sizes. Northhouse et al. (20 10) recommended further research on interventions targeted towards caregivers who are at higher risk for poorer outcomes (e.g. caregivers of advanced cancer patients) and interventions to assess the potential use of technology in delivering efficacious int erventions to this caregiver population. Providing supportive services to family caregivers in rural areas , with inflexible work schedules, and /or with lack of time is a particular challenge (Anderson et al., 2011; Washington et al., 2015) . The use of technology to deliver psychosocial interventions may help to mitigate logistic and geographic barriers. Use of technology in psychosocial i nterventions As ment ioned above, t he re has been increased advocacy for the use of technology to deliver support to caregivers (Reinhard et al., 2015) . The burden s , challenges , and stress ors associated with caregiv ing may affect caregiver well being and can lead to social isolat ion and lack of time to reflect on own needs and feelings (Candy et al., 2011) . T he use of technology to de liver innovative and convenient behavioral health interventions to support cancer caregivers can improve coping and reduc e symptoms such as depression and anxiety without the added burden of having to attend a face to face session (Laudenslager et al., 2015; L. L. Northouse et al., 2012) . According to the National Alliance for Caregiver s , a large majority of family caregivers believed that using caregiving technologies such as video phone systems and a caregiving coordination system would be personally beneficial, would save them time, make caregiving
10 easier logistical ly , increase self efficacy, and reduce stress ( e Connected Family Caregiver: Bringing Caregiving into the 21st Century , 2011) . In particular, mobile technologies such as telehealth have been effectively implemented in family caregiver populations without the need for face to face interactions and may help to overcome some of the logistical and geographical barriers (Chi & Demiris, 2015; DuBenske et al., 2014) . Tele health is a mode of delivering health care services and information through telecommunication technology and is additiona lly commonly used to deliver educational interventions, consultation services and behavioral interventions . It can also be used as a means of improving social support, collecting care management data, symptom monitoring, and clini cal care delivery (Chi & Demiris, 2015) . In a systematic review assessing teleh ealth tools and support to family caregivers , m ore than 95 percent of the 65 studies included in the systematic review reported significant improvement in psychosocial outcomes (Chi & Demiris, 2015) . Telehealth studies conducted on rural family caregivers as well as telehealth studies conducted in a home setting found significant improvements in psychological health and quality of life of family caregivers. Additionally, family caregivers reported hig h levels of satisfaction and comfort with using telehealth. These findings suggest family caregiver s of patients who need round the clock care and symptom monitoring can utilize telehealth interventions for efficient care while reducing the burden of trave ling to medical clinics . While the evidence on the effect of telehealth interventions on family caregivers is encouraging , f urther attention is needed to identify the most effective technologies for family caregivers of cancer patients . T here are currentl y very few examples of evidence based technological interventions aimed at helping family caregivers of cancer patients manage their stress (Pensak et al., 2017) .
11 The PsychoEducation and Paced Respiration and Relaxation (PEPRR) Program The PsychoEducation and Paced Respiration and Relaxation or PEPRR P rogram is an evidence based intervention tailored to meet the needs of caregivers of allo HSCT patients . The psychosocial program is an 8 session in person intervention that was adapted and tested with caregivers of patients who underwent an allogeneic transplant. The PEPRR session s were adapted from a cognitive behavioral stress management (CBSM) intervention p reviously developed for breast cancer patients (Antoni et al., 2009) . The PEPRR intervention was tailored to meet the specific needs of cancer caregivers with the aim of enhanc ing caregiver self care and improving adaptive coping skills. The cognitive component of the PEPR R intervention centered around promoting adaptive coping skills through cognitive behavioral strategies . Results of the PEPRR intervention indicate that the inter vention effectively reduced perceived stress, anxiety, and depress ion in caregivers three months post transplant (Laudenslager et al., 2015) . The PEPR R intervention was also deemed feasible and acceptable such that 70 percent of caregivers completed all eight sessions and participants reported high levels of satisfaction with the intervention (Simoneau, Kilbourn, Spradley, & Laudenslager, 2017) . However, authors noted that dissemination of the intervention would be challenging and al ternative methods for providing caregiver support such as via the phone or video chat , are needed , particularly for those caregivers who are too overwhelmed to attend in person intervention sessions (Laudenslager et al., 2015; Simoneau et al., 2017) .
12 METHODS Purpose and Specific Aims of the C urrent S tudy The current study wa s a descriptive sub study of the previously described RCT pilot project aimed at demonstrating the feasibility and estimating the efficacy of an evidence based mobile application that integrate d psychoeducation and skills based training program (Pep Pal) for informal caregivers of advanc ed cancer patients. This sub study utilized a mixed methods methodology that include d both quantitative data from the 26 intervention participants and select qualitative data from the first eight caregiver partic i pants who complete d the Pep Pal interventio n to assess feasibility, acceptability , and usability of the Pep Pal mobile program . The quantitative data was extracted from demographic questionnaires, specific post intervention questionnaires and other project records for all the partic i pants. Additi onally, a subset of eight caregivers participate d in a 60 90 minute semi structured individual interviews , which assess ed the helpfulness and utility of the Pep Pal program. Pep Pal wa s delivered via a mobilized website that wa s accessible anytime by smartphone, computer, tablet, or laptop. The Pep Pal intervention consist ed of 9 sessions that were each less than 10 minutes (see Appendix A). The 9 sessions include d 1.) Introduction to Stress Management 2.) Stress and the Mind Body Connection 3.) How ou r Thoughts Can Lead to Stress 4.) Coping with stress 5.) Strategies for Maintaining Energy and Stamina 6.) Coping with Uncertainty 7.) Managing Relationships 8.) Getting the Support you Need 9.) Improving were included o n the mobilized website. Mini Peps were brief (less than two minutes each) video guided activities. Video guided activities include d relaxation exercises (e.g. body scan, deep breathing, and mindfulness meditation) and mood exercises (e.g., gratitude exerc ises) and relationship enhancement activities (e.g., communication
13 exercises) (see Appendix B). The current qua litative descriptive study examine d the formative feasibility, acceptability , and usability of the mobilized based Pep Pal program. For the purp ose of this study, feasibility was defined by at least 50 % of eligible caregivers enrolling in Pep Pal and at least 50 % of enrolled intervention caregivers completing seven out of nine full wa s based on previous criteria for similar intervention completion in a prior trial with advanced cancer patients as well as professional stakeholder feedback for recommended (Greer et al., 2012; Pensak et al., 2017) . The study examine d specific components of feasibility of the Pep Pal program through the analysis of participation rates, reasons for non participation and/or drop out, and the number of Pep P al sessions completed. This include d quantitative analysis of all of the RCT study participants randomized to the intervention condition as well as those who were approached for participation. Acceptability of the inte rvention was defined as the participants self report of satisfaction with the delivery method of the intervent ion, the timing and order of the sessions, helpfulness of the individual sessions, and the web based format of the Pep Pal intervention. Acceptability was established quantitatively by the Helpfulness of the Intervention Sessions Q uestionnaire on a 0 to 10 Likert scale that was completed by all participants randomized to the intervention (Appendix E ). Acceptability o f the Pep Pal intervention was also established through the tallying and qualitative assessments of questions three , four , six , nine , and ten from the qualitative interview (Appendix F and Table 2 ) . Usability wa s defined as the perceived user friendliness of the platform from which it was delivered . Usability will be assessed through the post assessment Pep Pal U sability Q uestionnaire (Appen dix E) which was completed by all the intervention participants , and
14 through the tallying and qualitative assessments of questions three , six , seven , and eight from the qualitative interview (Appendix F and Table 2 ) . Table 1 includes the data that was used to assess feasibility, usability, and acceptability for the purpose of this study . Table 1 . Key outcomes measures Key outcomes: Source of data: Feasibility (includes all participants ) Participation rates (%) Project records and demographics variables Reasons for non participation Project records Pep Pal sessions completed ( > 7 sessions) Project records and demographic variables Acceptability: satisfaction with the following: Delivery method Semi structured exit interviews Timing of sessions Semi structured exit interviews Format Semi structured exit interviews Helpfulness of intervention sessions Helpfulness of Intervention Sessions Questionnaire Usability Pep Pal usability First five items on the Pep Pal Usability Questionnaire User friendliness of intervention First five items on the Pep Pal Usability Questionnaire, semi structured exit interviews Table 2 . Process E valuation Q uestions from Semi structured Interviews Acceptability 3. When you think about Pep Pal, what comes to mind about your experience using it? (value judgment of it/ sense of it/ reaction to it) a. What was your reaction to it? b. What was your sense of it? 4. How has Pep Pal, the intervention, been helpful for you? a. In what ways in particular? b. If discuss mini peps, probe full sessions? (and vice versa) 6. What was your experience like using Pep Pal? a. (experience actually using it) b. Run me through it. What was your experience like? How did you use the Pep Pal program? Run me through using it on a typical day. c. Context around when and how they used it.
15 9. Were any videos more helpful than others? a. Which videos and why? b. Tell me about those? c. Can you give me an example of how it was/ they were helpful? 10. Were any videos less helpful than others? a. Which videos and why? b. Tell me about those videos that were less helpful? i. How long do you think the videos should be? ii. It sounds like some of the videos were less engaging than others? Do you remember which ones? iii. one? iv. c. In what way were they least helpful can you give me an example? d. If there is a negative reaction to the intimacy session probe: If there were a session to replace the intimacy session, what would that look like? Why? Usability: 3. When you think about Pep Pal, what comes to mind about your experience using it? (value judgment of it/ sense of it/ reaction to it) a. What was your reaction to it? b. What was your sense of it? 6. What was your experience like using Pep Pal? a. (experience actually using it) b. Run me through it. What was your experi ence like? How did you use the Pep P al program? Run me through using it on a typical day. c. Context around when and how they used it. 7. Did you watch any videos? 8. How did you watch the videos? (e.g., on laptop, computer, tablet, smartphone)? S pecific a ims: Aim 1: The study examine d specific components of feasibility of the Pep Pal program through the analysis of participation rates , reasons for non participation and/or drop out , and the number of Pep Pal sessions completed . This aim include d quantitati ve analysis of all of the RCT study participants randomized to the intervention condition as well as those who were approached for participation. Feasibility of the Pep Pal intervention w ill be successfully established by at least 50% of eligible caregiver s enrolling in Pep Pal and at least 50% of enrolled intervention caregivers completing seven out of nine full length sessions.
16 Hypothesis 1: The Pep Pal will be sho wn to be feasible based on the criteria listed above. Aim 2: This study examine d the acceptability of the Pep Pal intervention through a mixed methods approach examining caregiver satisfaction for those who were randomized to the intervention condition. Satisfaction with the delivery m ethod of the intervention, timing of sessions , he lpfulness of the individual sessions, and the overall web based format of the intervention was assessed . Acceptability of the Pep Pal intervention will be established quantitatively by the Helpfulness of the Intervention Sessions Q uestionnaire which assessed satisfaction and helpfulness of different aspects of the program on a 0 to 10 Likert scale. Acceptability of the Pep Pal intervention will also be established through the tallying and qual itative assessments of questions three , four , six , ni ne , and ten from the qualitative interview . Hypothesis 2: Participants will rate the intervention as acceptable as measured by mean helpfulness scores at or above a rating of 5 out of 10 . Aim 3: This study examine d the usability of the intervention through a mixed methods approach examining the responses to questions about the usability of the intervention for those who were randomized to the intervention condition. Usability was assessed using the Pep Pal Usability Q uestionnaire which was administer ed post intervention, and the semi structured exit interviews. Hypothesis 3: The majority of caregivers will rate the usability of the Pep Pal intervention as above average on the Likert scale based quantitative analysis of the Pep Pal Usability questionnaire .
17 Participants Participants enrolled in the larger RCT study if they identified as a primary caregiver , the and provides instrumental care such as transportation for a patient . The primary caregiver also identif ied as a caregiver of a patient who receiv ed HSCT, enrolled in a phase I oncology clinical trial, or wa s diagnosed with advanced cancer (stage IV, solid tumor). Additional inclusion criteria include d , 1) participants over the age of 18, 2) they can read and speak English, 3) they do not have cognitive or psychiatric conditions prohibiting participation (e.g., significant developmental or intellectual disab ility ) , 4) they endorse d a moderate level of anxiety (e.g., greater than or equal to eight on the HADS A), and , 5) they had a computer, laptop, smartphone, or tablet with internet access. Rationale for the screening cut off score of 8 or above on the HAD S A wa s that a score of eight or above is clinically significant for anxiety and depressive symptoms in medical populations (Bjelland, Dahl, Haug, & Neckelmann, 2002; Zigmond & Snaith, 1983) . There wer e no other inclusion/ exclusion criteria (see Appendix C ) . Procedur es The procedures fo r the larger randomized study include d the recruitment of potentially eligible caregivers (see Participants above) from one of three settings at an academic medical center; the hematopoietic stem cell transplants (HSCT) unit, the phase I oncology t rials clinic, and the hematolo gy/oncology clinic. Enrollment into the study and written informed consent t oo k place during one of the treatment visits or provider appointments. Potential participants were deemed eligible after completing the HA DS A with a total score of eight or above. Study
18 staff review ed all study procedures, the consent form, and the data collection procedures with potentially eligible participants . After the caregiver consented to the RCT, the study staff administer ed the ba seline questionnaires. Following the baseline self report questionnaires, randomization occur red , set by the study statistician . Randomization was completed after baseline ass essment to minimize bias. Participants were randomly assigned to receive either the Pep Pal mobilized intervention in addition to treatment as usual or assigned to the treatment as usual group. Study staff provided access to the mobilized website (passcode) through an email for caregivers randomly assigned to the Pep Pal mobilized intervention. Caregivers were instructed to watch ea ch session at least once. It was recommended that caregivers watch one to two new sess ions per week so that they could have enough time to practice the skills between ses sions. In addition, they were told they can go back and watch the sessions for review as many times as they like. Study staff provide d instructions on how to navigate t he program either on the phone or in person (if within the wee k of consent). T welve week s after study enr ollment, study participants were sent the post assessment questionnaire via email. Additionally, study staff contact ed a subgroup of ( n = 8) intervention post assessment completers to conduct a semi structured qualitative interview (see Appendix F ) . This study examine d the responses to some of the selected questionnaires administered to all the intervention participants and the responses to the semi structured interviews that were conducted with the eight intervention completers . The rand omized control trial was approved by the Colorado Multiple Institutional Review Board. Data c ollection measures Demographic q uestionnaire . Each caregiver participant complete d a demographic questionnaire at baseline that includes information on age, sex, race, ethnicity, marital status, religion, relation to the patient, education level, living context (e.g., number of children in
19 (see A ppendix D ). Demographic v ariables from the baseline questionnaire were used to assess which variables were associated with caregiver completion and non completion of the intervention. Pep Pal usability questionnaire. Each intervention caregiver comple te d the Pep Pal U sability questionnaire at post assessment that include s nine questions regarding the experience of using the Pep Pal website on a 5 point Likert scale to measure the strength of the agreement or disagreement with each statement. Higher total scores indicate increas ed usability (Appendix E). For the purpose of this project, the first five items of the measure were used to assess the usability of the web based platform. Helpfulness of intervention sessions questionnaire. Each intervention caregiver complete d the Helpfulness of Intervention S essions questionnaire at post assessment that include 10 questions regarding the helpfulness of each intervention session on a 10 point Likert scale to measure the level of helpfulness of each session. Higher total scores indicate increased helpfulness (Appendix E). Semi structured interview . A semi structured interview guide was used by study staff to conduct the qualitative interviews with caregivers of the first 8 intervention study completers. The interview guide cover ed topics such as caregiver challenges ( e.g., What have been the , the most helpful Pep Pal videos ( e.g., ) , the least helpful Pep Pal videos ( e.g., ) , areas for improvement in the program ( e.g., What suggestions do you have to improve Pep ), and desirable features to be added ( e.g., We are interested in adding new features to the program. Would you be interested in: Caregiver reported patient symptom monitoring and graphs over
20 ) (Appendix F ) . The semi structured interview questions helped assess the usability and acceptability of Pep Pal during this stressful time in their lives. Data a nalysis This is a mixed methods analysis and the sub study data include d analyse s of both quantitative and qualitative data. Descriptive statistics was conducted on all program completers base line demographic questionnaire using SPSS version 24 . We used descriptive statistics to explore goals of Aim 1, analyses evaluate d the key outcomes such as response rate, number of sessions completed, reasons for nonparticipation for all intervention participants . The assessment of usability and acceptability of the intervention caregivers outlined in Aims 2 and 3 include d means and proportions from the Pep Pal U sability Q uestionnaire and the Helpfulness of I ntervention S essions Q uestionnaire . The qualitative data from the i nterviews , which was audio recorded and transcribed, were analyzed using a pplied thematic analysis , an inductive approach, to draw out broad themes and subthemes within the data (Braun & Clarke, 2006) . Data analysis involve d the systematic organization of the data through open coding in Atlas.ti and repeated continuous comparisons across coded data to identify salient themes. A team approach was used to synthesize and contextualize the dat a. Team members (AC and JJ) independently review ed transcripts and me t regularly to discuss emerging themes, discr epancies, and alternative explanations. Ongoing modifications to the conceptual framework of themes wa s a fundamental part of the analytic process. Data saturation was reached when no new themes emerge d regarding key outcomes. The key outcome questions an d measures examined for Aims 1 through 3 are included in Table 1 and Table 2 .
21 RESULTS The results described below include quantitative and qualitative data analysis used to determine the feasibility, acceptability, and usability of the Pep Pal program (Aims 1 3) . Feasibility of the P ep Pal Intervention Feasibility of the Pep Pal intervention was assessed via recruitment rates , as defined as at least 50% of eligible participants enrolling in Pep Pal after completion of the baseline assessment, partic ipation rates as defined as the percentage of enrolled participants completing post assessment outcome measures, and intervention completion rate which was defined as completing at least seven out of nine full length sessions. Over an 11 month accrual period, a total of 189 participants were approached for screening , 161 participants were screened which is a recruitment rate of 85% . Of those screened, 75 met the screening criteria and 72 completed the baseline assessment . Of the 75 participants who enrolled in the study , 56 completed the post intervention assessment resulting in 74.6% study retention rate. A flow chart of the study is included in Figure 1. D emographic characteristics of the 72 participants that completed the baseline assessment are displayed in Table 3. Of the 72 participants who completed the baseline assessment, 36 were randomized to the intervention. Of these 36 participants, five partic ipants were lost to follow up for the following reasons: study withdrawal ( n =2), patient death ( n =2), and technology issues ( n =1). Twenty nine participants (81%) completed at least one session and 10 participants completed at least seven out of the nine fu ll length sessions, resulting in a 27 . 7 % intervention completion rate. Participants randomized to the i ntervention group who completed less than seven full length Pep Pal sessions ( n =16) were more likely to be older ( M =55.58, SD =15.15), have dependent children living with them ( 37.5%), and began caregiving at the time the patient initially became ill ( 56.3%). In terms of the full length Pep Pal session completed, t here was an even split among
22 exit interviewees , with 50% (4/8) of exit interviews having c ompleted greater than seven out of the nine full length sessions and 50% (4/8) of exit interviewees having complet ed less than seven o ut of nine full length sessions. Fig ure 1. Study Flow Chart
23 Table 3 . Demographics and key characteristics at baseline by group (N= 72 ) Characteristics Pep Pal TAU 3 6 36 Caregiver age (years), mean (SD) 5 5 . 7 (1 4 . 6 ) 5 4 . 7 (1 1 . 4 ) Female caregiver, n (%) 24 ( 66 . 7 %) 2 6 (7 2 . 2 %) Married/ Civil Union, n (%) 2 8 (7 7 . 8 %) 31 (86. 1 %) Relationship to the patient, n (%) Spouse/ Civil partner College degree, n (%) Total annual income $75,000, n (%) 2 7 (7 5 . 0 %) 1 9 ( 52. 8 %) 22 (6 1 . 2 %) 30 (83.3%) 1 1 ( 30 . 5 %) 20 ( 61 . 1 %) Living with the patient, n (%) 31 (8 6 . 1 %) 32 (8 8 . 9 %) Dependent children, n (%) Employment status before caregiving, n (%) Full time Part time On leave Unemployed Retired Current employment status as a caregiver, n (%) Full time 24 ( 66 . 7 %) 21 (5 8 . 3 %) 7 ( 19 . 4 %) 2 ( 5 . 6 0%) 6 (1 6 . 7 %) 1 7 (4 7 .2%) 9 (2 5 . 0 %) 24 (6 6 . 7 %) 5 (1 3 . 9 %) 2 ( 5 . 6 0%) 5 (13. 9 %) 1 7 (4 7 . 2 %) Part time On leave Unemployed Retired 7 ( 19 . 4 %) 4 ( 11 . 1 %) 8 (2 2 . 2 %) 7 ( 19 . 4 %) 1 (2.80%) 3 ( 8 .30%) 8 ( 22 . 2 %) Patient felt ill prior to diagnosis, n (%) 22 (6 1 . 1 %) 20 (5 5 . 6 %) Chronic health issues prior to diagnosis, n (%) 7 ( 19 . 4 %) 3 ( 8 . 3 %) Caregiving responsibilities began, n (%) At the time the patient became ill 19 ( 52 . 8 %) 9 (2 5 .0%) At the time the patient was diagnosed 14 ( 38 . 9 %) 2 1 ( 58 .3%) Prior to the time the patient was diagnosed 1 ( 2 . 8 0%) 3 ( 8 . 3 0%) Other Caregiver stress levels increased at the time the patient became ill, n (%) Caregiver first began to have emotional concern, or stress in relation At the time the patient became ill At the time the patient was diagnosed Prior to the time the patient was diagnosed Other 2 ( 5 . 6 0%) 35 (9 7 . 2 %) 1 1 ( 30 .6%) 22 ( 61 .1%) 2 ( 5 . 60 %) 1 ( 2 . 8 0%) 3 ( 8 . 3 0%) 3 5 (9 7 . 2 %) 10 (2 7 . 8 %) 1 9 (5 2 . 8 %) 6 (1 6 . 7 %) 1 ( 2 . 8 0%)
24 Acceptability of the Pep Pal i ntervention Acceptability is typically defined as level of satisfaction with an intervention session or program . The acceptability of the Pe p Pal information was determined via Helpfulness of Intervention Sessions Questionnaire that was included in the post assessment and five open ended questions that were included in the post intervention semi structured exit interviews with the first eight intervention completers (see Tabl e 2) . Participants ( n =26) rated each intervention session as acceptable as measured by mean helpfulness scores at or above a rating of 5 out of 10 for nine out of the ten intervention sessions . The intervention session with the highest mean rated helpfulness score ( M =6.88 , range = 10, SD =3.31) was the introductory video Pal , which oriented users to the purpose of the Pep Pal program and how to best utilize the program. Intervention sessions with the second highest mean rated helpfulness scores included Body ( M =5.88, range = 10, SD =3.44), M =5.88 , range = 10, SD M =5.88 , range =10, SD ( M =5.88 , range = 10, SD = 3.68). These stress management intervention sessions were designed to promote effective coping strategies through cognitive behavioral strategies with the intent to reduce caregiver related distress and promote caregiver self efficacy (Simoneau et al., 2017) . was the third highest rated helpful intervention session ( M =5.85 , range =10, SD = 3.41) . This session was led by an expert clinician and introduced concepts of stress management as well as broadly discussed the caregiver experience. The remaining participant rated acceptable intervention sessions included session content that emphasized caregiver self car e as a mechanism to enhance successful caregiving practices ( ; M =5.62 , range =10, SD =3 .55), importance of types of social support network and potential barriers in obtaining
25 social support ( ; M =5.54 , range =10, SD=3.60), and utilization of various communication styles to enhance communication with the patient and medical team ( ; M = 5.38 , SD = 3.44) . The participant reported intervention session that was not deemed acceptable was mproving I ntimacy ( M = 4.19, range =10, SD = 3.805; see Table 4.), which address ed ways to improve intimacy and caregiver patient relationships. Acceptability of the intervention sessions was further assessed from exit interviews through the tallying and qu alitative assessments of questions three, four, six, nine, and ten from the qualitative interviews . When asked about an appropriate length for the full session in general, 50 % (4/8) of the qualitative participants indicated that they were satisfied with t he current 10 to 20 minute full session length and 37.5% (3/8) of qualitative participants indicated the full sessions could have been shorter, 10 minutes or less, in length. Exit interview data suggested that participants were satisfied with the delivery method of Pep about the Pep said : It [ the Pep Pal program] gave me a place to go and get information without having to go to the doctor or go to his doctor or call somebody. I could just do it on my own time and when I needed it the most. Whether it was early in the morning when I to it. Overall, 87.5% (7/8) exit interviewees indicated sessions related to stress management helped caregivers understand the mental and physical impacts of stress as well as d evelop helpful
26 coping strategies such as relaxation exercises to manage their stress. One caregiver commented on her experienc e developing effect ive relaxation techniques using this session: Every time I felt like I was getting stressed or I felt myself g etting tense or then hold it and then release it. A nd just do that for a minute or several minutes. It just really helped. K ind of calmed myself down and go t my heart rate down. It just made me feel better actually. Another caregiver indicated sessions related to stress reduction was more applicable to her current caregiving experience and were easier to follow along with , I found the stress reduction and self help and self care as more engaging than the ot I would say probably because it was more related to what I was dealing with but visually I would say were The majority of exit interviewees ( 87.5%, 7/8) commented on how helpful the session, in regard to putting their self care needs first by planning personal goals . One caregiver described how this session helped her consider her own self care needs: The one that was like planning personal goals for myself. And I remember sitting because I forget to do that. And that was really helpful that I have to remember to think about myself. So that was the biggest thing that I got from t hat was the reminder that I have to think about Additionally, 62.5% (5/8) of exit interviewees described s helpful reminder on the importance of support and encouraged caregivers to
27 overcome their own difficulties in asking for help to meet their supportive needs. One caregiver described how this session provided her with a new perspective on how to ask for support : But its helped because it helped me with su pport . T here was a video and my because I feel like then I am becoming a burden. And so, when it said people are there to help you to not be afraid and to get the help that helped a lot because then it had me kind of put down my wall and listen . Qualitative analysis ( N about the session video content and was more about the degree to which the topic of sexual intimacy applied to each caregiver patient relationship. One participant said : an issue for us right now. I mean, he is in a lot of pain. We do have intimate times of Another participant said : your husband i peopl e.
28 Table 4 . Helpfulness of Intervention Sessions Questionnaire and sessions viewed Pep Pal N=26 Exit Interviewees N=8 Pep Pal Sessions Viewed a N= 26 Session: M (SD) M (SD) n (%) Introduction to Pep Pal 6.88 (3.31) 5.88 (3.09) 22 (84.6%) Introduction to Stress Management 5.85 (3.41) 7.00 (1.92) 22 (84.6%) Stress and the Mind Body Connection 5.88 (3.44) 6.75 (2.05) 17 (65.4%) How our Thoughts can Lead to Stress 5.88 (4.46) 7.00 (1.85) 17 (65.4%) Coping with Stress 5.88 (3.59) 7.13 (1.95) 11 (42.3%) Strategies for Maintaining Energy and Stamina 5.62 (3.55) 6.50 (2.20) 15 (57.7%) Coping with Uncertainty 5.88 (3.68) 7.13 (2.29) 13 (50.0%) Managing Relationships/ Communicating Needs 5.38 (3.44) 6.38 (2.13) 12 (46.2%) Getting the Support you Need 5.54 (3.60) 6.13 (2.58) 12 (46.2%) Improving Intimacy 4.19 (3.80) 5.88 (2.53) 13 (50.0%) a Proportion of P ep Pal participants who actually viewed full length sessions. Usability of the Pep Pal Intervention For the purpose of this project, usability is defined as the perceived experience of us efulness of the web based platform from which it was delivered. Usability was assessed on a one to five Likert scale using the first five items of the Pep Pal Usability Questionnaire which was administered post intervention, and qualitatively through the semi structured exit interviews. M ean scores above a three indicate d user agreement and with the each of the first five items from the Pep Pal Usability Questionnaire. The above average mean usability ratings from the Pep Pal Usability Questionnaire: ( M =4.15, range = 4, SD =1.22 Pal website very M =4.38, range = 2, SD Pal website were well M =4.19, range = 3, SD =0.89. The mean users confid ence in navigating the website , was a ssessed by the following statement , Pal
29 ( M =4.38, range = 3, SD =0.69) suggest ing tha t users agreed with the statement and felt confident in using the web based platfor m. User s found disagreement with the this Pep M =2.58, range = 4, SD =1.13), suggesting users perceived experience in using the intervention was more sporadic and less consistent (See Table 5 ). Qualitative analysis regarding the perceived experienci ng using the web based platform highlights how 75% (6/8) of exit interviewees felt the web based user interface was well laid out and easy to use. One participant said : designed, wise process. I imagine for extremely helpful because it is not cluttered . I n terms of modality used to access the Pep Pal program, 37.5% (3/8) of exit interview participants indicated they used their smartphone, 37.5% (3/8) used their computer or laptop, and 25% (2/8) indicated they used their iPad or tablet. The smartphone exit interview users ( n=3 ) indicated they would have preferred a mobile application instead of a web based format for the Pep Pal intervention to improve internet connectivity issues during their commute to work. Desp ite a n even split between participant reported computer/laptop versus smartphone modality, one participant indicated he would have preferred using his tablet throughout the study but encountered technological issues in this modality : , but it would not work. That was using a droid [Android] tablet and on a computer and that was IBM windows that worked fine. The password and everything worked fine. When I tried using it on my tablet it would just not load up.
30 However, t his was the only exit interviewee self reported incident of technological modality issues to study staff , which was reported to study staff post study completion . Table 5 . Pep Pal Usability Questionnaire Pep Pal N=26 M (SD) Exit Interviewees N=8 M (SD) I used this Pep Pal website frequently. 2.58 (1.13) 3 .00 (1.06) The Pep Pal website was easy to use. 4.15 (1.22) 4.25 (1.38) The various functions in this Pep Pal website were well organized. 4.19 (0.89) 4.38 (1.06) Most people would learn to use the Pep Pal website very quickly. 4.38 (0.63) 4.63 (0.51) I felt very confident using the Pep Pal website. 4.38 (0.69) 4.63 (0.51) DISCUSSION The prima r y goal of this study was to evaluate the feasibility, acceptability, and usability of a mobilized psychoeducation and skills based program for caregivers of patients with advanced cancer. A mixed methods design was utilized in order to get a more in depth Feasibility of the Pep Pal intervention was defined as at least 50% of eligible caregivers enrolling in Pep Pal and at least 50% of enrolled intervention caregivers completing seven out of nine full l ength sessions. Acceptability o f the intervention was defined as mean helpfulness scores at or above a rating of 5 out of 10 on the 10 item Helpfulness of Intervention Sessions Questionnaire . Lastly, u sability of the intervention was defined as the perceiv ed experience of usability , as assessed by mean usability scores at or above a rating of four out of ten on the first five items of the Pep Pal Usability
31 Questionnaire o n the web based platform from which it was delivered. Overall, t he Pep Pal intervention was able to successfully recruit caregivers of patients with advanced cancer into the study although fewer than 50% of caregivers enrolled in the intervention condition completed seven out of nine sessions. The intervention was deemed accepta b le on nine out of the ten intervention session as evident by mean individual scores on the Helpfulness of Intervention Sessions Questionnaire at or above a five out of ten . Finally , the web based platform was deemed usable as evident by exit interviews and mean ratings that were at or above a ra ting of four out of five on the Pep Pal Usability Questionnaire . More specific information regarding these findings are included below. Of the 189 caregivers who were approached for this study, 161 agreed to undergo screening . Those who declined to be screened for the study reported that they were feeling too overwhelmed given their caregiving responsibilities ( n =17) or did not self identify as distressed ( n =10). The demand on caregiver population. Nevertheless, eight five percent of eligible participants enrolled in the Pep Pal program which met our first criteria for feasibility . The remaining four percent of eligible partic ipants , based on the distress screening criteria, enrolled in the program but failed to complete baseline questionnaires. One of those participants that did not complete baseline questionnaires was deemed ineligible after enrollment by study staff and was withdrawn from the study . Four caregivers withdrew from the study due to feeling overwhelmed by study time commitments and three caregivers withdrew from the study because of the death of their loved one. Despite , our ability to successfully recruit caregi vers of patients with advanced cancer into the study , only 27 . 7 % of intervention participants completed great or equal to seven out of the nine full length sessions and 19 . 4 % of participants viewed all nine of the sessions . Our decision
32 to use seven out of nine sessions as our intervention feasibility criteria was based on other psychosocial clinical trials (Greer et al., 2012) as well as feedback from stakeholders in the formative dev elopment of the program (Pensak et al., 2017) . In addition to the full length sessions, the Pep Pal program included Mini Pep sessions. Mini Peps are video guided activities that are less than two minutes each and include relaxation exercises (e.g. body scan, deep breathin g, and mindfulness meditation) and mood exercises (e.g., gratitude exercises) and relationship enhancement activities (e.g., communication exercises). Mini Peps served as a brief supportive exercise option for program engagement for those caregivers with v ery limited time. The mini peps also serve as a means to maximize convenient dissemination of resources. Despite the low intervention completion rate, an additional four intervention group participants completed six out of the nine full length sessions and either watched a full session multiple times or watch ed greater or equal to three mini peps during their time in the intervention. Thirty three percent ( n =12) of participants viewed at least one Mini P ep . ( n =6 ( n n =1) were the least viewed session s . As mentioned above, an a priori feasibility criterion of 75% (the equivalent to completing at least seven out of the nine full length session s) was based on previous criteria for similar psychosocial intervention trials with advanced cancer patients as well as professional stakeholder recommendation dosage from pilot data used in the formative development of the Pep Pal Program (Greer et al., 2012; Pensak et al., 2017) . In addition, Pep Pal is a supportive resource for the hardest to reach caregivers with significant barriers to their own self care. The Pep Pal intervention differed from the similar psychosocial intervention R CT trial in that Pep Pal was developed for distressed caregivers of advanced cancer patients and had a total of nine full -
33 length sessions while the RCT was developed for high ly anxious terminal cancer patients and had a total of six in person CBT sessions. Additionally, t he web based intervention was harder to facilitate and control engagement of participants compared to similar psychosocial interventions that were conducted face to face or via telephone (Greer et al., 2012; Simoneau et al., 2017) . Also, unlike traditional interventions, the Pep Pal intervention allowed caregivers to repeat sessions t hat may have been especially relevant to their caregiving experience. Of the 36 intervention participants, 15 participants (41.6%) re watched at leas t one full length session during their 12 weeks in the program. The Pep Pal intervention was deemed acceptable on nine out of ten intervention sessions based on scores at or above five out of ten on the Helpfulness of the Intervention Sessions Questionnaire, which assessed satisfaction and helpfulness of different asp ects of the program on a 0 to 10 Likert scale. The majority of intervention participants rated the Pep Pal intervention sessions as helpful with a mean helpfulness score of five or above for all sessions except for pfulness score of 4.19 ( SD =3.80). The session that was least commonly viewed among post caregivers Pep the most viewed sessions among post assessment intervention caregivers. It is important to note that despite positive perceptions of the helpfulness of sessions in the program, on ly a small group of participants actually viewed all of the sessions. A mixed methods approach was utilized to further understand the below average ratings for the session on intimacy. When further examining qualitative data, exit interviewees reported the apparent low ratings for helpfulness were associated with the function of sexual intimacy in
34 each unique caregiver patient relationship and not about the expert clinician led content of the ot what it was. That whole part, we are kind of recapturing it. The Pep an inconspicuous challenge in her current caregiver distress : se xual intimacy fit within the caregiver patient relationship instead of needed adaptations to the content of the session. Several exit interviewees indicated the intimacy session provided a new perspective on how intimacy can be defined to include non sexu al activities to recapture meaning in their relationship. One caregiver elicited feedback on the new perspective the intimacy session provided in the caregiver patient relationship : ywhere forefront. To have some just some time to be close and intimate with each other. Qualitative data is suggestive that the provided intimacy session strategies to improve communication and intimacy helped the caregiver s adjust to relationship changes associated with their loved . Given the exit interviewee responses to the topic of the session. For the purpose of this project, usability was defined as the perceived experience of using and working with the web based intervention and the platform from which it was delivered.
35 The usability of the web based platform was assessed via questions from the Pep Pal Usability Questionnaire (Questions 1, 2, 3, 4, 5) and qualitative data from the eight post intervention interviews. The analysis of the first five questions from the Pep Pal Usability Q uestionnaire suggest users agreed with stat ements regarding the following components of the web based platform the website was M =4.15, SD M =4.19, SD ( M =4.38, SD = 0.63), and ( M = 4. 38, SD =0.69 ). The Pep Pal intervention met the criteria for usability of the web based platform based on the quantitative ratings of perceived program usabilit y . Of the eight exit interviewees , six indicated that the program was well designed , easy to use and regardless of user technological ability. Overall, t h ese findings describe users perceived experience of the web based platform as simple in user interface, intuitive to the average technology user, and well designed . In terms of perceived experience of using and working with the Pep Pal program , users I used this Pep M =2.58, SD =1.13) and this item did not successfully meet usability criteria of an above average Likert scale r ating of four out of five on the Pep Pal Usability Questionnaire. This may highlight barrie rs of program utilization with t he web based platform given the high demand s of caregiving . Although the present study suggests relatively low intervention adherence rates, there are encouraging results from caregiver ratings of the acceptability of intervention sessions as well as perceived usability of the web based delivery platform. Potential reasons for the low adherence rates may include a number of factors. First, the modality of smartphone delivery may have been hard to use for some caregivers and affected the perceived experience of using and working with the intervention. Second, the in tervention was self paced, self led, and intervention chose the
36 order of sessions to view. Third, the intervention not include any personal direction, which may have helped caregivers navigate the web based platform. This study adds to the caregiver distre ss research literature base and builds on pilot feasibility studies in this area of caregiver evidence based interventions dissemination using mobile technologies. Lastly , it should be noted that the Pep Pal program was not meant to replace in person psychosocial treatment for cancer caregivers. Rather, Pep Pal wa s designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until additional support can be obtained. In addition, Pep Pal is not size fits such as face to face, online, or both . Pep Pal is one example of an evidenced based program that was adapted in o rder to provide a flexible resource for those caregivers who have significant barriers to receiving in person supportive care or who prefer the flexibility of a web based intervention . Limitations There are s everal limitations worth mentioning . The gener alizability of the intervention is limited by the following: First, there was a small sample size ( N =26 for quantitative measures, 8 for qualitative) , which creates a relatively homogenous group of caregivers ; Second , the majority of intervention caregivers were white, female, spousal caregivers who were caring for cancer patient who were being treated in three different clinics (Medical Oncology , n = 22, Phase I , n = 11, BMT , n =3) ; Third , this study involved a small qualitative sample of bo ne marrow transplant intervention caregivers, wh i ch does not mirror the larger quantitative sample which included a mix of caregivers who were caring for cancer patients who were recruited from medical oncology, the BMT clinic and the Phase I trial cl inic.
37 T echnological interventions can yield their own challenges , such as internet connectivity issues and the technological challenges associated with the platform that was used to view the intervention (e.g., smartphone, iPad, computer, etc.). This may have altered the experience in using the program and impacted both satisfaction with the intervention and the participant ability to view and interact with the various sessions thus leading to lower rates of viewing. The type of intervention may have led to a select group of caregivers who chose to participate in the study. Eighty five percent of those caregivers that were approached agreed to be screened for the study and we were unable to collect information on those who refused to participate . This may have excluded a portion of highly distressed caregivers. All intervention post assessment participants completed all 10 questions from the Helpfulness of Interven tion Sessions Questionnaire despite only a limited number of intervention post assessment participants having watched these sessions (see Table 4). These differences add a limitation to the validity of the helpfulness ratings given that not all interventio n post assessment participants watched sessions they rated. Finally, there were limitations associated with the way that the criteria for the number of sessions viewed was assessed. The criteria failed to incorporate caregiver preferences for mini peps g iven their availability as well as the need to re watch sessions given their supportive needs, which would have altered the intervention session completion findings. This led to a more stringent representation of completion rates for the intervention sessi ons. Had the mini peps and viewing the same session multiple times been incorporated into the feasibility criteria, the Pep Pal intervention would have been deemed feasible with 13/26 participants completing greater or equal to seven out of nine sessions i n general.
38 Conclusions, I mplications and F uture D irections The results of this project suggest that the Pep Pal program, a psychoeducation and skills based intervention designed to meet the needs of caregivers of patients with advanced cancer, was deemed feasible, showed good acceptability for nine out of ten of t he intervention sessions , and met the criteria for usability of the web based platform . Our findings suggest a number of potential adaptations to th e Pep Pal program For example, the removal of the HADS A screening criteria would allow for a broader range of caregivers of advanced cancer patients to participate in future refinements of the program . Th e absence of a screening tool wa s also seen in the in person evidenced based feasibility and acceptability psychosocial trial , which the Pep Pal program was adapted after (Simoneau et al., 2017) . Additionally, f ewer sessions would likely improve adherence to the intervention. Sessions related to stress management were the highest rated in terms of acceptability. Encouraging users to watch the first four to five full length sessions on stress manage ment as well as instruct users to watch the remaining optional sessions could improve users exper ience in using and working with the intervention. This would also give users more direction and structure in how to prioritize sessions and use the web based i ntervention. Furthermore, using an assessment based algorithm would recommend optional sessions to care givers. For example, female caregiver s that reports female sexual dysfunction as measured by total scores on the Female Sexual Function Index (FSFI) baseline measure (Baser RE, Li Y, 2012) would receive a notification on the Pep Pal website to watch the recommend Improving Intimacy An additional feature to the program could include expert clinician led forum online where expert clinicians could lead discussions on topics such as caregiver self care and provide intervention caregivers the opportunity to ask questions. This feature w ould supplement the full -
39 length session on care. This would allow for a n additional optional feature in the pr ogram for those caregivers that may need a more structurally guided approach to their self care. The development of a mobile application that can be used on smartphones may also improve accessibility of the intervention. This pilot feasibility study serves to better inform and guide the main study design of a mobilized program in order to be tested in a multi site efficacy study in order to improve quality of life and reduce distress for caregivers of patients with advanced ca ncer . Once efficacy of the study is established, Pep Pal could be used to supplement caregiver in person psychotherapy or compliment the utilization of caregiver support groups. This research will inform and allow for an evidence based, convenient and easily disseminated intervention to be a resource for caregivers to help manage their distress.
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44 APPENDIX A Pep Pal Full Length Sessions
46 APPENDIX B Mini Pep Pal Sessions
47 APPENDIX C Consort Diagram
48 APPENDIX D Caregiver Demographics Questionnaire Please complete the Caregiver Demographics survey below. _________________ (Month/Day/Year) 2.) Date of Birth _________________ (Month/Day/Year) Age _________________ 3.) Gender Female Male 4.) Marital Status Single Committed Relationship Married/ Civil Union Separated Divorced Widowed 5.) Relationship to the patient Spouse/ Civil Partner Sibling Parent Child Partner Friend Other If other, please specify: _________________ 6.) What is the highest level of education you have completed? Grade School or less Some high school or technical school High school or technical school graduate Some col lege College graduate Some graduate or professional school after college
49 Completed advanced degree 7.) What, if any, is your religious preference? Protestant Catholic Evangelical LDS/ Mormon Jewish Muslim Hindu Buddhist Other No Preference/ No religious affiliation Prefer not to say (optional) 8.) Do you live with a patient? Yes No What is your approximate total household annual income before taxes and other deductions? Less than $25,000 $25,000 $49,999 $50,000 $74,999 $75,000 $99,999 $100,000 $199,999 Greater than $200,000 Prefer not to answer 9.) Employment status BEFORE taking on caregiver responsibilities? Full time Part time On leave Unemployed Retired If full time, how many hours per week? _________________ (Hours) If part time, how many hours per week? _________________ (Hours) 10.) What is your CURRENT employment status as a caregiver? Full time Part time On leave Unemployed
50 Retired If full time, how many hours per week? _________________ (Hours) If part time, how many hours per week? _________________ ( Hours) Are you receiving paid leave to care for your patient? Yes No 11.) Are you being paid to take care of your patient? Yes No Racial/ Ethnic Identity 12.) How do you racially describe yourself? American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander White/ Caucasian More than one race Another group not listed If it is another group not listed, please specify _______________________ 13.) Ethnicity (Choose the one with which you MOST CLOSELY identify) Hispanic or Latino Not Hispanic or Latino We are trying to understand how your own stress, worry, and health have been affected by ver. _______________________ (Type) 15.) If you are a caregiver of a bone marrow transplant patient, when was their transplant date (past or future)? _ ______________________ (Choose Allo Transplant or Auto Transplant) (Month/Day/Year) 16.) How many hours a week do you spend caregiving on average? ______________________ (Hours) 17.) When was the patient diagnosed with their current Illness/ cancer? ______________________ (Month/Year) 18.) Often, a patient is feeling ill prior to diagnosis, was
51 it the case for your patient? Yes No 19.) Did the patient have chronic health issues prior to diagnos is of cancer? Yes No If yes, please explain ______________________ 20.) How frequently do you have caregiver worries and/or stress? 0 5 10 Rarely or Sometimes Most of the time none of the time 21.) When did you first begin having emotional concern, At the time that the patient became ill At the time that the patient was diagnosed Prior to the time the patient was ill and diagnosed Other If other, please explain ________________________ illness? Yes No If yes, when: At the time that the patient became ill At the time that the patient was diagnosed Prior to the time the patient was i ll and diagnosed Other If other, please explain ________________________ 23.) When did your caregiving responsibilities begin (this includes taking the patient to doctor appointments,
52 helping with medications, providing emotional suppo rt)? At the time that the patient became ill At the time that the patient was diagnosed Prior to the time the patient was ill and diagnosed Other If other, please explain ________________________ 24.) Do you have dependent children living with you? Yes No How many? ________________________ (Number) Ages of children ________________________ (use a comma to separate ag es) 25.) Considering your role as a caregiver, please check the issues that come up for you so that we can better understand your problem and issues. (check all that apply) Increased worry Less sleep Less time to care for myself Less time to exercise on a regular basis Poor nutrition Other If other, please list ________________________ 26.) What techniques do you currently use to manage stress as related to caregiving duties (or life in general)? (check all that apply) Engaging in exercise/ physical activity Professional psychological services (counseling, psychotherapy) Integrated therapies massage, acupuncture, energy healing, etc. Music or art Religion/ spiritual activities Relaxation in hobbies or interest Other None If other, please list ________________________
53 APPENDIX E Pep Pal Usability Questionnaire Instructions: Please respond to each of the following statements by checking one of the boxes in each row with respect to your experience using the Pep Pal program that you received during your participation in the study. Strongly Disagree Disagree Neutral Agree Stron gly Agree 1. I used this Pep Pal website frequently. 2. The Pep Pal website was easy to use. 3. The various functions in this Pep Pal website were well organized. 4. Most people would learn to use the Pep Pal website very quickly. 5. I felt very confident using the Pep Pal website. 6. The Pep Pal program was helpful towards managing my stress as a caregiver. 7. The Pep Pal website improved interactions between me and the loved one I am caring for. 8. Using the Pep Pal website helped to reduce the burden of caregiving. 9. Using the Pep Pal website improved my interpersonal situation.
54 10. The Mini Pep videos were helpful towards managing my stress as a caregiver. Helpfulness of Interv e ntion Sessions: Please rate all of the sessions ranging from not at all helpful to very helpful: Introduction to Pep Pal not at all helpful 0 --------------------------very helpful 10 Introduction to Stress Management Stress and the Mind Body Connection How our Thoughts can Lead to Stress Coping with Stress Strategies for Maintaining Energy and Stamina Coping with Uncertainty Managing Relationships/Communicating Needs Getting the Support you Need Improving Intimacy 1. What suggestions do you have to improve Pep Pal? ______________________ Is there be anything we could do to improve the full sessions?__________ _____________________________________________________________ Is there be anything we could to improve the mini peps?_______________ _____________________________________________________________ 2. We are interested in adding new features to the program. Would you be interested in: A chat room with other caregivers? Yes No Direct messaging with your medical team providers? Yes No Monitoring your loved ones' symptoms over time with ratings and graphs to show trends? Yes No Connections to local caregiver support resources? Yes No
55 Tools to remind you about medications for your loved ones (e.g., alerts)? Yes No Expert clinician led forums online? For example, an expert clinician would lead a discussion about different topics related to caregivers and self care and provide you with the opportunity to ask questions. Yes No 3. We are interested in adding new features to the program. Would you be interested in: Would you want any other topics to be covered in the full length modules? For example, a lot of caregivers have difficulties at work. Would you like a video for how to handle work stress or cope with work? Yes No What about a full session on how to improve sleep? Yes No What about a session on how to make meaning out of the caregiving experience? For example to discover, reconnect, and maintain a s ense of meaning even during times of stress in caregiving? Or to gain a greater understanding of meaning and space to explore Yes No Are there any other topics you would like to see covered in this program? If so, what topics? ________________________________________________________________________ ___________________________________________
56 APPENDIX F Semi Structured Interview Guide A Randomized Controlled Trial of Mobilized Psychoeducation and Skills Based Intervention (Pep Pal) for Caregivers of Patients with Advanced Illness : QUALITATIVE INTERVIEW GUIDE FOR INDIVIDUAL EXIT INTERVIEWS Before beginning the interview, please be sure of the following: The participant has completed the informed consent process. There is a separate number file with a study ID code. Each question that is numbered is asked, and that the sub questions are probes to be asked if they are not answered by the initial question. After each question , ask if there is anything else they think is important to know about. Check the digital recorder. Interview Guide Introduction and Framing Hello, my name is ____________. I am (describe affiliation with the study). You have been asked to participate in this interview to provide feedback on a mobilized intervention to reduce distress in caregivers of patients with advanced illness. We are interested to know your thoughts about the program, whether you believe it was helpful, and if you have any concerns or suggestions to improve it. We greatly appreciate your willingness to participate in this study. As a reminder, everything that you share with me today is confidential and your answers will not affect your future participation in studies o r your access to medical or psychotherapy services. I would like to audio record this interview because I will not be able to write all of this information down. The interview will be transcribed word for word and will allow us to capture your thoughts and feelings in your own words. No identifying information, such as your name or names of others, will be included in the transcript. This interview, including reviewing the components of the mobile application, will take one study visit lasting between 60 90 minutes.
57 There are no right or wrong answers to these questions. We want to know your impressions of this mobile application and it is very important for us to hear your thoughts and feelings. (TURN ON RECORDER) Do I have permission to record this interview? Before we start, do you have any questions about what we are doing here today? Intervention Arm 1. How were the last 12 weeks for you taking care of your loved one? 2. What have been the biggest challenges for you over the last 12 weeks while taking care of your loved one? 3. When you think about Pep Pal, what comes to mind about your experience using it? (value judgment of it/ sense of it/ reaction to it) a. What was your reaction to it? b. What was your sense of it? 4. How has Pep Pal, the intervent ion, been helpful for you? a. In what ways in particular? b. If discuss mini peps, probe full sessions? (and vice versa) 5. In what way did the program come at the right time? a. Others have told us they would have preferred this at the beginning of caregiving what would you say to that? 6. What was your experience like using Pep Pal? a. (experience actually using it) b. Run me through it. What was your experience like? How did you use the pep pal program? Run me through using it on a typical day. c. Context around when and how they used it. 7. Did you watch any videos? 8. How did you watch the videos? (e.g., on laptop, computer, tablet, smartphone)? 9. Were any videos more helpful than others? a. Which videos and why? b. Tell me about those?
58 c. Can you give me an example of how it was/ they were helpful? 10. Were any videos less helpful than others? a. Which videos and why? b. Tell me about those videos that were less helpful? i. How long do you think the videos should be? ii. It sounds like some of the videos were less engaging than others? Do you remember which ones? iii. one? iv. c. In what way were they least helpful can you give me an example? d. If t here is a negative reaction to the intimacy session probe: If there were a session to replace the intimacy session, what would that look like? Why? 11. What suggestions do you have to improve Pep Pal? a. What about the sessions would there be any thing we could do to improve the full sessions? b. What about the mini peps would there be any thing we could to improve the mini peps? c. Would you want any more interactive features? For example, a chat room with other caregivers? Expert clinicians guiding discussions on different topics? i. Expert clinicians What topics would be helpful? 12. We are interested in adding new features to the progra m. Would you be interested in: a. Other features direct messaging with providers? b. Caregiver reported patient symptom monitoring and graphs over time? i. For example, you said your husband has pain and sometimes his pain is worse at times than others. Would it b e helpful to see this in a picture , so you would know what times of day he might have more pain? 1. Can be reassuring to know symptoms can come and go in waves? c. Connections to local resources? d. Medication adherence tools? i. Would you like an alarm in your ph one Pa l program to remind you to give medications at a certain time? e. What about direct messaging with your medical team providers (i.e. triage nurse)? f. What about a full session on pain management? g. What about local caregiver resource supp ort services (use locally i.e. food delivery services)? h. Expert clinician led forums online? For example, an expert clinician would lead a discussion about different topics related to caregivers and self care and provide you with the opportunity to ask qu estions. 13. We are interested in adding new features to the program. Would you be interested in: a. Would you want any other topics to be covered in the full length modules? For example, a lot of caregivers have difficulties at work. Would you like a video for how to handle work stress or cope with work? b. If you were to design the program moving forward, what else would you add?
59 c. What about a full session on how to improve sleep? d. What about a session on how to make meaning out of the caregiving experience? i. For e xample to discover, reconnect, and maintain a sense of meaning even during times of stress in caregiving. ii. Or to gain a greater understanding of meaning and space to explore your 14. Finally, is there anything you important for you and your loved one? We have now reached the end of this interview. Thank you for being a part of the study. We appreciate your valuable and thoughtful responses. END