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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
69
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.
University of Colorado, Denver
Aurora, Colorado, United States
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.
Time frame: 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.
Time frame: 12 weeks
Evaluation of Self-Report Caregiver reported outcomes at Baseline
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Time frame: Week 1
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Time frame: Week 12
Evaluation of Self-report caregiver reported outcomes at baseline
Center for Epidemiologic Studies Depression Scale (CESD)
Time frame: Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Perceived Stress Scale (PSS)
Time frame: Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Female Sexual Function Index (FSFI)
Time frame: Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Male Sexual Health Questionnaire(MSHQ)
Time frame: Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Measure of Current Status (MOCS-A)
Time frame: Week 1
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Center for Epidemiologic Studies Depression Scale (CESD)
Time frame: Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Perceived Stress Scale (PSS)
Time frame: Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Female Sexual Function Index (FSFI)
Time frame: Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Male Sexual Health Questionnaire(MSHQ)
Time frame: Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Measure of Current Status (MOCS-A)
Time frame: Week 12
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