Promoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedMay 29, 2025
May 1, 2025
1.8 years
February 10, 2023
May 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
3RP-VHL Feasibility: Percent of Identified Eligibles Who Enroll
Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline).
Post-treatment completion (treatment is approximately 2 months)
3RP-VHL Feasibility: Proportion of Participants Completing the 3RP-VHL Program
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.
Post-treatment completion (treatment is approximately 2 months)
3RP-VHL Acceptability: Five Questions
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.
Post-treatment completion (treatment is approximately 2 months)
Study Arms (1)
3RP-VHL
EXPERIMENTAL* 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.
Interventions
An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals with VHL.
Eligibility Criteria
You may qualify if:
- Ages 18+
- Confirmed diagnosis of VHL
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- The Rappaport Foundationcollaborator
- The Claflin Distinguished Scholar Awardscollaborator
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giselle Perez, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2023
First Posted
February 21, 2023
Study Start
July 30, 2024
Primary Completion
May 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
May 29, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.