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Promoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05737602
Collaborator
The Rappaport Foundation (Other), The Claflin Distinguished Scholar Awards (Other)
40
Enrollment
1
Location
1
Arm
27
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Relaxation Response Resiliency Program (3RP) has shown efficacy in improving coping and resilience across diverse populations; however, little is known about how it helps individuals manage the challenges of living with a chronic illness. This study proposes to pilot test an adapted version of the 3RP among patients living with VHL.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 3RP-VHL
 N/A

Detailed Description

The 3RP has not been carried out with VHL patients. As such, the investigators are looking to see if an adapted program, tailored to the needs of patients with VHL, is feasible, acceptable, and helpful in improving coping among individuals living with VHL.

This study is a two phase trial. Phase I is descriptive. It is comprised of conducting interviews with patients and caregivers to understand the challenges of living with VHL and patient's programatic needs. This information will be used to tailor the program for patients living with VHL. Phase II is a single-arm feasibility trial that will examine if the adapted program is feasible, acceptable, and helps promote stress management among VHL patients. To these means, we will test the adapted 3RP (3RP-VHL) in up to 40 patients living with VHL. Participants will complete surveys at baseline and post 3RP-VHL program completion. This record will reflect the trial component (Phase II) only, as feasibility and acceptability outcomes will be collected for this phase.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Promoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3RP-VHL

An adapted version of the 3RP (3RP-VHL) for individuals with VHL. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies. It will be delivered in weekly sessions over the course of approximately 8 weeks. Complete pre- and post-intervention surveys.

Behavioral: 3RP-VHL
An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals with VHL.
Other Names:
  • Relaxation Response Resiliency Program for VHL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 3RP-VHL Feasibility: Percent of Identified Eligibles Who Enroll [Post-treatment completion (treatment is approximately 2 months)]

      Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline).

    2. 3RP-VHL Feasibility: Proportion of Participants Completing the 3RP-VHL Program [Post-treatment completion (treatment is approximately 2 months)]

      Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Participants who complete at least 75% of the treatment sessions (6 out of 8 sessions) will be identified as treatment completers.

    3. 3RP-VHL Acceptability: Five Questions [Post-treatment completion (treatment is approximately 2 months)]

      Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). More specifically, acceptability will be defined as ≥75% of responses rated at least 3/4 on enjoyableness, convenience, helpfulness, future use, and satisfaction.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ages 18+

    • Confirmed diagnosis of VHL

    Exclusion Criteria:

    • Is medically, psychiatrically, or otherwise unable to participate (as determined by a physician or study PI).

    • Unwilling or unable to participate in study sessions delivered via Partners Telehealth videoconferencing.

    • Participated in Phase 1 qualitative interview.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • The Rappaport Foundation
    • The Claflin Distinguished Scholar Awards

    Investigators

    • Principal Investigator: Giselle Perez, PhD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Giselle K. Perez Lougee, Principal Investigator, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT05737602
    Other Study ID Numbers:
    • 22-612
    First Posted:
    Feb 21, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Giselle K. Perez Lougee, Principal Investigator, Massachusetts General Hospital
    Von-Hippel-Lindau Disease
    VHL
    Genetic Disorder
    Additional relevant MeSH terms:
    Von Hippel-Lindau Disease
    Genetic Diseases, Inborn

    Study Results

    No Results Posted as of Feb 21, 2023