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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 29
Healthy Volunteers: f
View:

⁃ To be eligible to participate in this study, YAs must meet all of the following criteria:

• Self-reported diagnosis of LFS.

• Aged 18 to 29 years at the time of enrollment.

• Ability to speak, read, and/or write in English (to understand and provide informed consent and participate in the study activities).

• Currently live in the U.S.

• Willing to engage in a demonstration of a mental health resource for YAs with LFS and provide feedback on it.

• Able to travel to the NCI Shady Grove Campus.

• Access to a computer, high-speed internet, and a webcam, which may be necessary if the study team cannot conduct the study at the NCI due to unforeseen circumstances (e.g., government policy, weather).

• Have not participated in a mindfulness- or compassion-based program within the past 6 months.

• Do not have a consistent meditation practice \>= 30 minutes per day.

⁃ Eligibility based on these inclusion criteria will be determined via an online screening questionnaire. To be eligible to participate in this study, non- YA stakeholders must meet all of the following criteria:

• At least age 18 at the time of enrollment.

• Ability to speak, read, and/or write in English (to understand and provide informed consent and participate in the study activities).

• Currently live in the U.S.

• Willing to observe a demonstration of a mental health resource for YAs with LFS and provide feedback on it.

• Able to travel to the NCI Shady Grove Campus.

• Access to a computer, high-speed internet, and a webcam, which may be necessary if the study team cannot conduct the study at the NCI due to unforeseen circumstances (e.g., government policy, weather).

Locations
United States
Maryland
NCI Shady Grove Campus
RECRUITING
Rockville
Contact Information
Primary
Camella J Rising, Ph.D.
camella.rising@nih.gov
(240) 276-5262
Backup
Payal P Khincha, M.D.
payal.khincha@nih.gov
(240) 276-7267
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2026-06-16
Participants
Target number of participants: 20
Treatments
Stakeholders
Other key stakeholders (non-YAs, non-NIH researchers), such as LFS clinicians, advocacy group representatives, and researchers will be referred by colleagues. Our goal is to enroll a minimum of 3 and a maximum of 6 individuals who have different LFS expertise (e.g., genetics providers, psychosocial researchers, LFS community leaders) to capture diverse viewpoints important to adaptation of evidence-based interventions.
YAs with LFS
Young Adults (18 up to 29 years old) who have been diagnosed with Li-Fraumeni Syndrome, half of whom have a cancer history and half of whom have no cancer history.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)
Collaborators: National Institutes of Health Clinical Center (CC)

This content was sourced from clinicaltrials.gov