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

NCT03002896 | Completed

• 1 other identifier: 16-0990
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Distress; Anxiety; Depression

Keywords

Cancer; Caregivers; Pep-pal; Pep-Pal + Treatment as Usual; Treatment as Usual

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Evaluation of Self-Report Caregiver reported outcomes at Baseline

  Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)

  Week 1

• Evaluation of Self-report caregiver reported outcomes at 12 weeks

  Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)

  Week 12

Secondary Outcomes (10)

• Evaluation of Self-report caregiver reported outcomes at baseline

  Week 1

• Evaluation of Self-report caregiver reported outcomes at baseline

  Week 1

• Evaluation of Self-report caregiver reported outcomes at baseline

  Week 1

• Evaluation of Self-report caregiver reported outcomes at baseline

  Week 1

• Evaluation of Self-report caregiver reported outcomes at baseline

  Week 1

Study Arms (2)

Pep-Pal + Treatment as Usual

EXPERIMENTAL

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; Other: Treatment as Usual

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Pep-Pal BEHAVIORAL

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.

Pep-Pal + Treatment as Usual

Treatment as Usual OTHER

Pep-Pal + Treatment as Usual; Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 33217070 DERIVED

• 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.

  PMID: 31066678 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Nicole R Amoyal-Pensak, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: December 26, 2016
• Study Start: December 1, 2016
• Primary Completion: November 17, 2017
• Study Completion: July 13, 2018
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)