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

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.

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

Conditions
-----------------
Von Hippel-Lindau Disease, Genetic Disorder

Intervention / Treatment
-----------------
* Behavioral: 3RP-VHL


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3RP-VHL<br>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<br>* An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals with VHL.<br>* Other names: Relaxation Response Resiliency Program for VHL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Von-Hippel-Lindau Disease, VHL, Genetic Disorder