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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002896
• Other study ID #: 16-0990
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: July 13, 2018

Study information

• Verified date: July 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Distress

Intervention

Behavioral:
• Pep-Pal
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.

Other:
• Treatment as Usual

Locations

Country	Name	City	State
United States	University of Colorado, Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

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