Stress Management Program for Von Hippel-Lindau Syndrome

Overseen By Giselle Perez, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Medical, psychiatric, telehealth, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a stress management program specifically designed for individuals with Von Hippel-Lindau syndrome (VHL), a rare genetic disorder that can cause tumors to grow in various parts of the body. The program, called 3RP-VHL, aims to help participants manage stress and improve their ability to cope with the challenges of living with a chronic illness. Participants will attend weekly sessions for about eight weeks, focusing on relaxation, understanding stress, and developing adaptive strategies. Ideal candidates are adults diagnosed with VHL who are comfortable attending sessions via video conferencing. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance stress management for those with VHL.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on stress management, so it's likely you can continue your medications, but please confirm with the study team.

What prior data suggests that this program is safe for individuals with VHL?

Research has shown that the Relaxation Response Resiliency Program (3RP) is generally safe. Studies have found that 3RP improves coping skills and resilience across various groups without major side effects. By focusing on stress management through relaxation and awareness techniques, the program avoids the usual concerns associated with medications or surgeries. To date, no serious problems have been reported from participating in 3RP. Participants can feel confident that the program is well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 3RP-VHL program because it offers a novel approach to managing stress for individuals with Von Hippel-Lindau Syndrome. Unlike current treatments that may focus on managing physical symptoms or surgical interventions, 3RP-VHL is designed to help patients recognize and cope with stress through a structured, eight-week program. This program incorporates relaxation techniques, stress awareness, and adaptive strategies, which are not typically emphasized in the standard care for this condition. By addressing the psychological aspects of living with VHL, 3RP-VHL has the potential to improve overall quality of life for patients in a unique way.

What evidence suggests that the 3RP-VHL program is effective for managing Von Hippel-Lindau Syndrome?

Research has shown that the Relaxation Response Resiliency Program (3RP) helps people improve their ability to cope with stress and become more resilient. The program teaches stress management and resilience-building techniques, which can enhance quality of life by reducing stress and anxiety. In this trial, participants will receive an adapted version of 3RP specifically for individuals with Von Hippel-Lindau (VHL), known as 3RP-VHL. Although specific data for people with VHL is limited, this adapted version aims to offer similar benefits. Participants may learn skills to better manage the challenges of living with VHL. ^{1 2 3 4 6}

Who Is on the Research Team?

Giselle Perez, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of Von Hippel-Lindau (VHL) disease, which is a genetic disorder. Participants must be able to engage in videoconferencing sessions and not have any medical or psychiatric conditions that would prevent full participation as assessed by a physician.

Inclusion Criteria

I have been diagnosed with Von Hippel-Lindau disease.

Exclusion Criteria

My doctor agrees I am fit to join a study.

Participated in Phase 1 qualitative interview

I am willing and able to attend sessions through video calls.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I - Descriptive

Conducting interviews with patients and caregivers to understand the challenges of living with VHL and patient's programmatic needs

Not specified

Phase II - Treatment

Testing the adapted 3RP-VHL program in up to 40 patients with weekly sessions over approximately 8 weeks

8 weeks

8 weekly sessions

Follow-up

Participants are monitored for feasibility and acceptability outcomes post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3RP-VHL

Trial Overview The study tests an adapted Relaxation Response Resiliency Program (3RP-VHL), designed to help VHL patients cope better with their condition. It's about learning stress management techniques specifically tailored for those living with this chronic illness.

How Is the Trial Designed?

Group I: 3RP-VHL Experimental Treatment 1 Intervention

* 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

The Rappaport Foundation

Collaborator

Trials

1

Recruited

40+

The Claflin Distinguished Scholar Awards

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

A 20-week contemplative self-healing program significantly improved the quality of life (QOL) for 46 breast and gynecologic cancer survivors, as evidenced by a mean increase of 6.4 points on the FACIT-G scale.

Participants also experienced notable reductions in anxiety and distress, along with biological improvements such as lower resting heart rates and better cortisol levels, indicating enhanced emotional and physical well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a contemplative self-healing program on quality of life in women with breast and gynecologic cancers. Loizzo, JJ., Peterson, JC., Charlson, ME., et al.[2022]

The SMART (Stress Management and Resiliency Training) program significantly improved resilience, reduced perceived stress and anxiety, and enhanced quality of life in 25 women with breast cancer over a 12-week period, compared to a control group.

The intervention, which included group training sessions and follow-up calls, was found to be feasible and effective, indicating that brief resilience training can be beneficial for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Loprinzi, CE., Prasad, K., Schroeder, DR., et al.[2022]

Cancer patients experience significant stress that can negatively impact their quality of life and may even promote tumor growth and metastasis, highlighting the importance of effective stress management.

Randomized controlled trials have shown that stress management interventions can improve psychological and physiological adaptation, potentially leading to better health outcomes for cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. Antoni, MH., Moreno, PI., Penedo, FJ.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05737602?term=AREA%5BBasicSearch%5D(Von%20Hippel-Lindau%20Disease%20(VHL))&rank=1

Promoting Stress Management and Resilience Among ... The Relaxation Response Resiliency Program (3RP) has shown efficacy in improving coping and resilience across diverse populations; however, little is known ...

2. withpower.com withpower.com/trial/phase-von-hippel-lindau-disease-3-2023-753ea

Stress Management Program for Von Hippel-Lindau ... The 3RP-VHL treatment is unique because it focuses on stress management and resilience training, which can improve quality of life and reduce stress and anxiety ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03075

A Relaxation Response Resiliency Program (3RP) to ... This clinical trial tests how well a relaxation response resiliency program (3RP) works in promoting stress management and resilience in patients with Von ...

4. trial.medpath.com trial.medpath.com/clinical-trial/3e2c1cdcaa4218da/nct05737602-promoting-stress-management-resilience-von-hippel-lindau-disease

Promoting Stress Management and Resilience Among ... The Relaxation Response Resiliency Program (3RP) has shown efficacy in improving coping and resilience across diverse populations; however, little is known ...

5. app.trialscreen.org app.trialscreen.org/trials/von-hippel-lindau-disease-promoting-stress-management-resilience-among-trial-nct05737602

Promoting Stress Management and Resilience Among ... Benefits: Participants may benefit from learning relaxation and resilience techniques that could help them better cope with the challenges of living with VHL ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12421775/

Narrative Review of Von Hippel-Lindau Syndrome This review emphasizes the importance of a multidisciplinary approach to managing VHL syndrome and explores emerging therapies that hold promise ...