Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness

Study Overview
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Brief Summary
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The proposed project is a pilot study of the Pep-Pal (Psychoeducation and Skills Based Intervention) versus a treatment as usual control group. A total of 60 caregivers; including caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), caregivers enrolled in Phase I clinical trials, and caregivers of patients with advanced cancer (Stage III, solid tumor) will be enrolled in this study. The investigators do not expect different outcomes from these three groups, rather these populations are selected to optimize recruitment within a short time frame. The caregivers will be randomized to either treatment as usual or Pep-Pal intervention.

Detailed Description
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The proposed project is a pilot study of the Pep-Pal intervention versus a treatment as usual control group. A total of 60 caregivers; caregivers of patients with HSCT, caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer (Stage IV, solid tumor) will be enrolled in this study. The investigators do not expect different outcomes from these three groups, rather these populations are selected to optimize recruitment within a short time frame. The caregivers will be randomized to either treatment as usual or Pep-Pal intervention. The proposed study population is based on prior research indicating that caregivers of patients receiving HSCT, caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer experience significant distress. In addition, an initial study of caregivers of patients receiving allogeneic-HSCT were able to benefit from a brief, cognitive behavioral stress management treatment approach. A study examining distress in phase I oncology clinical trial patient caregivers highlighted the need for more support for this significantly distressed population. Furthermore, initial results of the qualitative development study for Pep-Pal yielded support for a mobilized platform delivery of resources for caregivers to manage distress because they acknowledged many barriers to engaging in in-person treatment to manage distress.

Official Title
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A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness

Conditions
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Distress, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Pep-Pal
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men ≥ 18 years of age of any ethnicity Must endorse a moderate level of anxiety (e.g. Score above an 8 on the Hospital and Anxiety Depression Scale (HADS)) Speak and read in English Caregiver of a patient with auto HSCT who are moving forward with bone marrow transplant or have receive a bone marrow transplant Caregiver of a patient in a Phase I Clinical Trial Caregiver of a patient diagnosed with advanced cancer (stage III or stage IV) No Cognitive or psychiatric conditions prohibiting participation Must meet criteria for being a primary caregiver, defined as, the person in the patient's life who is primarily responsible for care decisions, emotionally invested in the patient's care, provides instrumental care such as transportation for a patient receiving auto-HSCT, enrolled in a phase I oncology clinical trial, or of a patient diagnosed with advanced cancer (stage IV, solid tumor). Have a computer, smartphone, or tablet with internet access Exclusion Criteria: Caregivers below the age of 18 Score below an 8 on the Hospital and Anxiety Depression Scale (HADS) Cannot speak and read in English Patient does not receive a bone marrow transplant Patient is not enrolled in a Phase I clinical trial Patient is not diagnosed with Stage III or Stage IV cancer Cognitive conditions prohibiting participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pep-Pal + Treatment as Usual<br>If the caregiver is assigned to the Pep-Pal intervention condition, the RA will provide access to the mobilized website (passcode) through an email. Caregivers will be instructed to watch each session at least once. It will be recommended that caregivers watch one to two new sessions per week so that they can have enough time to practice the skills between sessions. In addition, they will be told that they can go back and watch the sessions for review as many times as they like. Full participation will be defined as watching at least 7/9 sessions (75% of program) based on previous criteria for similar intervention completion in a prior trial with advanced cancer patients. | Behavioral: Pep-Pal<br>* Pep-Pal is designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until greater resources can be obtained. In this way, Pep-Pal is a resource for our most hard to reach caregivers.<br>Other: Treatment as Usual<br> <br> |
| Active Comparator: Treatment as Usual<br>Treatment as usual provides voluntary (at the caregiver's discretion) support services for the caregivers which is rarely used by the caregivers. | Other: Treatment as Usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Exit Interviews | Qualitative feedback will be gathered from the first 15 Pep-Pal completer's for individual interviews (5 from Phase I group, 5 from Hematopoietic stem cell transplantation (HSCT) group, 5 from medical oncology) upon completion of the follow-up assessments at 12 weeks about usage, acceptability of content, and impressions of using Pep-Pal. | 12 weeks | 
| Pep-Pal Self-Report sessions at 12 Weeks | The Investigators will assess feasibility by examining recruitment, retention, as well as reasons for refusal, frequency of sessions watched and length of time spent watching each session. Self report usage of peppal: Usage of Pep-Pal will be quantitatively assessed by asking each participant in the intervention group about their usage including frequency; how many times they watched each session and length of viewing for each session (partial or complete). They will be asked to rate level of usage based on a Likert-scale ranging from not at all to very often for each session (0-10). They will be asked to rank order the list of sessions from most helpful to least helpful. | 12 weeks | 
| Evaluation of Self-Report Caregiver reported outcomes at Baseline | Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) | Week 1 | 
| Evaluation of Self-report caregiver reported outcomes at 12 weeks | Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Self-report caregiver reported outcomes at baseline | Center for Epidemiologic Studies Depression Scale (CESD) | Week 1 | 
| Evaluation of Self-report caregiver reported outcomes at baseline | Perceived Stress Scale (PSS) | Week 1 | 
| Evaluation of Self-report caregiver reported outcomes at baseline | Female Sexual Function Index (FSFI) | Week 1 | 
| Evaluation of Self-report caregiver reported outcomes at baseline | Male Sexual Health Questionnaire(MSHQ) | Week 1 | 
| Evaluation of Self-report caregiver reported outcomes at baseline | Measure of Current Status (MOCS-A) | Week 1 | 
| Evaluation of Self-report caregiver reported outcomes at 12 weeks | Center for Epidemiologic Studies Depression Scale (CESD) | Week 12 | 
| Evaluation of Self-report caregiver reported outcomes at 12 weeks | Perceived Stress Scale (PSS) | Week 12 | 
| Evaluation of Self-report caregiver reported outcomes at 12 weeks | Female Sexual Function Index (FSFI) | Week 12 | 
| Evaluation of Self-report caregiver reported outcomes at 12 weeks | Male Sexual Health Questionnaire(MSHQ) | Week 12 | 
| Evaluation of Self-report caregiver reported outcomes at 12 weeks | Measure of Current Status (MOCS-A) | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Caregivers, Pep-pal, Pep-Pal + Treatment as Usual, Treatment as Usual