Promoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 3RP-VHL Feasibility: Proportion of Participants Completing the 3RP-VHL Program
Study Overview
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.
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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 3RP-VHL (Behavioral)
Outcomes
Primary Outcomes
3RP-VHL Feasibility: Proportion of Participants Completing the 3RP-VHL Program
Time Frame: 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.
3RP-VHL Feasibility: Percent of Identified Eligibles Who Enroll
Time Frame: 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).
3RP-VHL Acceptability: Five Questions
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Giselle K. Perez Lougee
Principal Investigator
Massachusetts General Hospital