Li-Fraumeni SyndromeNCT07032922
Exploring How to Adapt an Evidence-Based Mindful Self-Compassion Program for Young Adults With Li-Fraumeni Syndrome
An observational study of Li-Fraumeni Syndrome, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Li-Fraumeni Syndrome
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study will enroll up to 14 Young Adults with Li-Fraumeni Syndrome and up to 6 key stakeholders.
Who may be able to join
- 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.
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- 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).
Who cannot join
- A YA who meets the following criteria will be excluded from participation in this study:
- 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.
- A non-YA stakeholder who meets any of the following criteria will be excluded from participation in this study:
- -Individuals who do not meet eligibility criteria listed. No other exclusionary criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Li-Fraumeni Syndrome
- Keywords
- Li-Fraumeni Syndrome, Mindful Self-Compassion (MSC), Young Adults, LFS, MSC, Mental Health
- Medical subject headings
- Li-Fraumeni Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To convene YAs with LFS and other key stakeholders to demonstrate core components of an evidence-based MSC program and obtain feedback on how to adapt the program for YAs with LFS
Measured: End of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start5 Jun 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Li-Fraumeni SyndromeStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Responsible party
- Sponsor
- Investigators
- Payal P Khincha, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032922
- Sponsor's protocol ID
- 10002467
- Other IDs
- 002467-C
- Status last verified
- 8 Dec 2025
- First submitted
- 19 Jun 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For privacy issues data will only be shared as aggregate data after publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring How to Adapt an Evidence-Based Mindful Self-Compassion Program for Young Adults With Li-Fraumeni Syndrome
- ClinicalTrials.gov ID
- NCT07032922
- Acronym / sponsor ID
- 10002467
- Conditions
- Li-Fraumeni Syndrome
- Keywords
- Li-Fraumeni Syndrome, Mindful Self-Compassion (MSC), Young Adults, LFS, MSC, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will enroll up to 14 Young Adults with Li-Fraumeni Syndrome and up to 6 key stakeholders.
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- A non-YA stakeholder who meets any of the following criteria will be excluded from participation in this study:
- -Individuals who do not meet eligibility criteria listed. No other exclusionary criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To convene YAs with LFS and other key stakeholders to demonstrate core components of an evidence-based MSC program and obtain feedback on how to adapt the program for YAs with LFS
Time frame: End of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No. For privacy issues data will only be shared as aggregate data after publication of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Payal P Khincha, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Li-Fraumeni Syndrome, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To convene YAs with LFS and other key stakeholders to demonstrate core components of an evidence-based MSC program and obtain feedback on how to adapt the program for YAs with LFS (time frame: End of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.