Depression Clinical Trial
Official title:
A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
NCT number | NCT03002896 |
Other study ID # | 16-0990 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | July 13, 2018 |
Verified date | July 2020 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | July 13, 2018 |
Est. primary completion date | November 17, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Women and men = 18 years of age of any ethnicity 2. Must endorse a moderate level of anxiety (e.g. Score above an 8 on the Hospital and Anxiety Depression Scale (HADS)) 3. Speak and read in English 4. Caregiver of a patient with auto HSCT who are moving forward with bone marrow transplant or have receive a bone marrow transplant 5. Caregiver of a patient in a Phase I Clinical Trial 6. Caregiver of a patient diagnosed with advanced cancer (stage III or stage IV) 7. No Cognitive or psychiatric conditions prohibiting participation 8. 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). 9. Have a computer, smartphone, or tablet with internet access Exclusion Criteria: 1. Caregivers below the age of 18 2. Score below an 8 on the Hospital and Anxiety Depression Scale (HADS) 3. Cannot speak and read in English 4. Patient does not receive a bone marrow transplant 5. Patient is not enrolled in a Phase I clinical trial 6. Patient is not diagnosed with Stage III or Stage IV cancer 7. Cognitive conditions prohibiting participation |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado, Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Evaluation of Self-Report Caregiver reported outcomes at Baseline | Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) | Week 1 | |
Primary | Evaluation of Self-report caregiver reported outcomes at 12 weeks | Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) | Week 12 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at baseline | Center for Epidemiologic Studies Depression Scale (CESD) | Week 1 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at baseline | Perceived Stress Scale (PSS) | Week 1 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at baseline | Female Sexual Function Index (FSFI) | Week 1 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at baseline | Male Sexual Health Questionnaire(MSHQ) | Week 1 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at baseline | Measure of Current Status (MOCS-A) | Week 1 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at 12 weeks | Center for Epidemiologic Studies Depression Scale (CESD) | Week 12 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at 12 weeks | Perceived Stress Scale (PSS) | Week 12 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at 12 weeks | Female Sexual Function Index (FSFI) | Week 12 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at 12 weeks | Male Sexual Health Questionnaire(MSHQ) | Week 12 | |
Secondary | Evaluation of Self-report caregiver reported outcomes at 12 weeks | Measure of Current Status (MOCS-A) | Week 12 |
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