Back to resultsMobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
Primary Purpose
Distress, Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pep-Pal
Treatment as Usual
Sponsored by
About this trial
This is an interventional supportive care trial for Distress focused on measuring Cancer, Caregivers, Pep-pal, Pep-Pal + Treatment as Usual, Treatment as Usual
Eligibility Criteria
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
Sites / Locations
- University of Colorado, Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pep-Pal + Treatment as Usual
Treatment as Usual
Arm Description
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.
Treatment as usual provides voluntary (at the caregiver's discretion) support services for the caregivers which is rarely used by the caregivers.
Outcomes
Primary Outcome Measures
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.
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.
Evaluation of Self-Report Caregiver reported outcomes at Baseline
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Secondary Outcome Measures
Evaluation of Self-report caregiver reported outcomes at baseline
Center for Epidemiologic Studies Depression Scale (CESD)
Evaluation of Self-report caregiver reported outcomes at baseline
Perceived Stress Scale (PSS)
Evaluation of Self-report caregiver reported outcomes at baseline
Female Sexual Function Index (FSFI)
Evaluation of Self-report caregiver reported outcomes at baseline
Male Sexual Health Questionnaire(MSHQ)
Evaluation of Self-report caregiver reported outcomes at baseline
Measure of Current Status (MOCS-A)
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Center for Epidemiologic Studies Depression Scale (CESD)
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Perceived Stress Scale (PSS)
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Female Sexual Function Index (FSFI)
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Male Sexual Health Questionnaire(MSHQ)
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Measure of Current Status (MOCS-A)
Full Information
NCT ID
NCT03002896
First Posted
September 28, 2016
Last Updated
July 31, 2020
Sponsor
University of Colorado, Denver
Collaborators
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT03002896
Brief Title
Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
Official Title
A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
July 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress, Anxiety, Depression
Keywords
Cancer, Caregivers, Pep-pal, Pep-Pal + Treatment as Usual, Treatment as Usual
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pep-Pal + Treatment as Usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual provides voluntary (at the caregiver's discretion) support services for the caregivers which is rarely used by the caregivers.
Intervention Type
Behavioral
Intervention Name(s)
Pep-Pal
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Primary Outcome Measure Information:
Title
Evaluation of Exit Interviews
Description
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
Title
Pep-Pal Self-Report sessions at 12 Weeks
Description
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
Title
Evaluation of Self-Report Caregiver reported outcomes at Baseline
Description
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Time Frame
Week 1
Title
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Description
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Evaluation of Self-report caregiver reported outcomes at baseline
Description
Center for Epidemiologic Studies Depression Scale (CESD)
Time Frame
Week 1
Title
Evaluation of Self-report caregiver reported outcomes at baseline
Description
Perceived Stress Scale (PSS)
Time Frame
Week 1
Title
Evaluation of Self-report caregiver reported outcomes at baseline
Description
Female Sexual Function Index (FSFI)
Time Frame
Week 1
Title
Evaluation of Self-report caregiver reported outcomes at baseline
Description
Male Sexual Health Questionnaire(MSHQ)
Time Frame
Week 1
Title
Evaluation of Self-report caregiver reported outcomes at baseline
Description
Measure of Current Status (MOCS-A)
Time Frame
Week 1
Title
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Description
Center for Epidemiologic Studies Depression Scale (CESD)
Time Frame
Week 12
Title
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Description
Perceived Stress Scale (PSS)
Time Frame
Week 12
Title
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Description
Female Sexual Function Index (FSFI)
Time Frame
Week 12
Title
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Description
Male Sexual Health Questionnaire(MSHQ)
Time Frame
Week 12
Title
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Description
Measure of Current Status (MOCS-A)
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole R Amoyal-Pensak, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33217070
Citation
Pensak NA, Carr AL, Jones J, Mikulich-Gilbertson SK, Kutner JS, Kilbourn K, Sannes TS, Brewer BB, Kolva E, Joshi T, Laudenslager ML. A pilot study of mobilized intervention to help caregivers of oncology patients manage distress. Psychooncology. 2021 Apr;30(4):520-528. doi: 10.1002/pon.5597. Epub 2020 Dec 2.
Results Reference
derived
PubMed Identifier
31066678
Citation
Carr AL, Jones J, Mikulich Gilbertson S, Laudenslager ML, Kutner JS, Kilbourn K, Sannes TS, Brewer BW, Kolva E, Joshi T, Amoyal Pensak N. Impact of a Mobilized Stress Management Program (Pep-Pal) for Caregivers of Oncology Patients: Mixed-Methods Study. JMIR Cancer. 2019 May 3;5(1):e11406. doi: 10.2196/11406.
Results Reference
derived
Learn more about this trial
Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
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