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NCT05126810 | Recruiting | Li-Fraumeni Syndrome

Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling
Sponsor:

M.D. Anderson Cancer Center

Brief Summary:

This study evaluates patients willingness to participate in a trial comparing standard genetic counseling versus personalized genetic counseling. Collecting information from patients may help researchers learn why patients may or may not take part in the future study that compares standard genetic counseling to personalized genetic counseling.

Condition or disease

Li-Fraumeni Membership

Intervention/treatment

Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVE: I. To evaluate patients' willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on Li-Fraumeni syndrome patient reported outcome (LFSPRO) ShinyApp data. OUTLINE: Patients complete a questionnaire over 15-20 minutes. Patients positive for a TP53 mutation complete an additional questionnaire over 15-20 minutes within 1 month after test results.}}

Study Type : Observational
Estimated Enrollment : 500 participants
Official Title : Evaluate Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling Based on LFSPRO-ShinyApp Data
Actual Study Start Date : November 3, 2022
Estimated Primary Completion Date : February 2, 2027
Estimated Study Completion Date : October 2, 2027

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Individuals age 15 or older OR parent/guardian of a patient younger than 15 years (if age 15-17, the patient will provide assent and parent/guardian will provide consent)
  • English fluency
  • Receive genetic counseling specifically for TP53 genetic testing and who consent to undergo TP53 genetic testing OR individuals whose genetic testing indicates a TP53 germline mutation
Exclusion Criteria
  • Individuals who are non-English speaking
  • Individuals having low suspicion for a TP53 germline mutation during pretest counseling and test negative for a TP53 mutation
Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling

Location Details

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Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030