RECRUITING

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

Conditions

Li-Fraumeni Syndrome Mindful Self-Compassion (MSC)Young Adults LFS MSC Mental Health

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-05

Study Completion:2026-06-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07032922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 29 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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. * 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).	* A Patient Health Questionnaire (PHQ-9) score or a General Anxiety Disorder (GAD-7) score \>= 15 at the time of screening. Scores \>= 15 correspond to moderately severe or severe depression and severe anxiety, respectively. The PHQ-9 and GAD-7 are standardized, validated measures of depression and anxiety. The data obtained from participants who are determined to be ineligible will not be retained in the database or system. Instead, it will be destroyed to ensure the privacy and confidentiality of the participants. * Individuals who do not meet eligibility criteria listed.

Inclusion Criteria

Exclusion 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.
* 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).

* A Patient Health Questionnaire (PHQ-9) score or a General Anxiety Disorder (GAD-7) score \>= 15 at the time of screening. Scores \>= 15 correspond to moderately severe or severe depression and severe anxiety, respectively. The PHQ-9 and GAD-7 are standardized, validated measures of depression and anxiety. The data obtained from participants who are determined to be ineligible will not be retained in the database or system. Instead, it will be destroyed to ensure the privacy and confidentiality of the participants.
* Individuals who do not meet eligibility criteria listed.

Contacts and Locations

Study Contact

Camella J Rising, Ph.D.

CONTACT

(240) 276-5262

camella.rising@nih.gov

Payal P Khincha, M.D.

CONTACT

(240) 276-7267

payal.khincha@nih.gov

Principal Investigator

Payal P Khincha, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

NCI Shady Grove Campus

Rockville, Maryland, 20850

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Payal P Khincha, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-05

Study Completion Date2026-06-16

Study Record Updates

Study Start Date2025-06-05

Study Completion Date2026-06-16

Terms related to this study

Keywords Provided by Researchers

Li-Fraumeni Syndrome
Mindful Self-Compassion (MSC)
Young Adults
LFS
MSC
Mental Health

Additional Relevant MeSH Terms

Li-Fraumeni Syndrome