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NCT Number: NCT05737602

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Von Hippel-Lindau Disease Abnormalities, Multiple Angiomatosis Cardiovascular Diseases Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Disorder Nervous System Diseases Neurocutaneous Syndromes Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3RP-VHL

Behavioral

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

Other names: Relaxation Response Resiliency Program for VHL

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • The Claflin Distinguished Scholar Awards
  • The Rappaport Foundation

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 21, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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