Exploring How to Adapt an Evidence-Based Mindful Self-Compassion Program for Young Adults With Li-Fraumeni Syndrome

Recruiting

• Conditions: Li-Fraumeni Syndrome

• Registration Number: NCT07032922
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Background:

Li-Fraumeni syndrome (LFS) is a genetic disorder that increases the risk of cancer. People who have LFS are 24 times more likely to develop cancer than those who do not. Past research studies have shown that living with high cancer risk can cause distress in young adults with LFS. Mindful self-compassion (MSC) is a therapeutic resource that has helped people with and without cancer cope with distress and other mental health challenges. Researchers at the National Cancer Institute (NCI) want to know if an MSC program can be adapted for young adults with LFS.

Objective:

Demonstrate and get feedback on an MSC resource for young adults with LFS.

Eligibility:

Young adults aged 18 to 29 years with LFS who have not participated in an MSC program in the past 6 months and who do not participate in daily meditation for 30 minutes or more. Individuals must be willing to travel to the National Cancer Institute for a one-day demonstration.

Design:

Participants will answer a short online questionnaire to determine study eligibility, which may include questions about cancer history and mental health. Eligible participants will attend an in-person demonstration of the MSC resource. A small group of other people, such as health care providers, may also attend. Participants will be invited to give their feedback on the MSC resource and discuss how to make it relevant and helpful for young adults with LFS.

The demonstration will be held at the NCI campus in Rockville, Maryland. If the demonstration cannot be held in person, it will be conducted virtually. The total time to participate will be about 5.5 hours.

Detailed Description

Study Description:

Young adults (YAs) with Li-Fraumeni syndrome (LFS) often experience high levels of distress and complex and dynamic health burdens. Evidence-based interventions that might ameliorate these challenges, such as a mindful self-compassion (MSC) program, have not been tested for acceptability and appropriateness among YAs with LFS. The aim of this study is to determine how to adapt an evidence based MSC program to meet the needs and preferences of this population. Data from this study will inform the development of an adapted MSC intervention to address a significant gap in LFS supportive care for YAs.

Objectives:

The primary objective of this study is to convene YAs with LFS and other key stakeholders (e.g., LFS clinicians) at the National Cancer Institute (NCI) to demonstrate core components of an evidence-based MSC program and obtain feedback on how to adapt the program for YAs with LFS.

Endpoints:

This is a descriptive study; therefore, we are not generating a priori hypotheses or measuring outcomes.

Study Timeline

• Study Start: 2025-06-05
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-19
• Study First Posted: 2025-06-24
• Status Verified: 2025-06-26
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-10-31
• Study Completion: 2026-06-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feedback on how to adapt an evidence-based MSC program for YAs with LFS	End of the study

Trial Locations

Locations (1)

NCI Shady Grove Campus; 🇺🇸 Rockville, Maryland, United States