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

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.

• INCLUSION CRITERIA:

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).

Exclusion criteria

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.