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

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ClinicalTrials.gov Identifier: NCT03002896
Recruitment Status : Completed
First Posted : December 26, 2016
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Distress Anxiety Depression Behavioral: Pep-Pal Other: Treatment as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
Actual Study Start Date : December 2016
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : July 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Pep-Pal + Treatment as Usual
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
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
Active Comparator: Treatment as Usual
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



Primary Outcome Measures :
  1. Evaluation of Exit Interviews [ Time Frame: 12 weeks ]
    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.

  2. Pep-Pal Self-Report sessions at 12 Weeks [ Time Frame: 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.

  3. Evaluation of Self-Report Caregiver reported outcomes at Baseline [ Time Frame: Week 1 ]
    Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)

  4. Evaluation of Self-report caregiver reported outcomes at 12 weeks [ Time Frame: Week 12 ]
    Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)


Secondary Outcome Measures :
  1. Evaluation of Self-report caregiver reported outcomes at baseline [ Time Frame: Week 1 ]
    Center for Epidemiologic Studies Depression Scale (CESD)

  2. Evaluation of Self-report caregiver reported outcomes at baseline [ Time Frame: Week 1 ]
    Perceived Stress Scale (PSS)

  3. Evaluation of Self-report caregiver reported outcomes at baseline [ Time Frame: Week 1 ]
    Female Sexual Function Index (FSFI)

  4. Evaluation of Self-report caregiver reported outcomes at baseline [ Time Frame: Week 1 ]
    Male Sexual Health Questionnaire(MSHQ)

  5. Evaluation of Self-report caregiver reported outcomes at baseline [ Time Frame: Week 1 ]
    Measure of Current Status (MOCS-A)

  6. Evaluation of Self-report caregiver reported outcomes at 12 weeks [ Time Frame: Week 12 ]
    Center for Epidemiologic Studies Depression Scale (CESD)

  7. Evaluation of Self-report caregiver reported outcomes at 12 weeks [ Time Frame: Week 12 ]
    Perceived Stress Scale (PSS)

  8. Evaluation of Self-report caregiver reported outcomes at 12 weeks [ Time Frame: Week 12 ]
    Female Sexual Function Index (FSFI)

  9. Evaluation of Self-report caregiver reported outcomes at 12 weeks [ Time Frame: Week 12 ]
    Male Sexual Health Questionnaire(MSHQ)

  10. Evaluation of Self-report caregiver reported outcomes at 12 weeks [ Time Frame: Week 12 ]
    Measure of Current Status (MOCS-A)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002896


Locations
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United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Nicole R Amoyal-Pensak, PhD University of Colorado, Denver
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03002896    
Other Study ID Numbers: 16-0990
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Cancer
Caregivers
Pep-pal
Pep-Pal + Treatment as Usual
Treatment as Usual
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms