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

M.D. Anderson Cancer Center500 enrolled

Overview

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.

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

Enrollment

500

Conditions

Li-Fraumeni Syndrome

Interventions

Questionnaire AdministrationOTHER

Complete questionnaire

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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), pregnant women will also be allowed to participate * 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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Patient willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on LFSPRO ShinyApp data

Time frame: Through study completion, an average of 1 year

Central Contacts

Banu Arun

CONTACT

713-792-2360 barun@mdanderson.org

Data from ClinicalTrials.gov

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