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

Genetic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737602
• Other study ID #: 22-612
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: Massachusetts General Hospital
• Contact: Giselle Perez, PhD
• Phone: (617) 724-0287
• Email: Gperez[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Diseases, Inborn
• Genetic Disorder
• Von Hippel-Lindau Disease

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	The Claflin Distinguished Scholar Awards, The Rappaport Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)