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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Li-Fraumeni Syndrome

Treatments: Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05126810

NCI-2021-10716 (Registry Identifier)

2021-0151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Observational (questionnaire)

Description:

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.

Treatment:

Other: Questionnaire Administration