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

Recruiting

• Conditions: Li-Fraumeni Syndrome
• Interventions: Other: Questionnaire Administration

• Registration Number: NCT05126810
• Lead 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-19
• Study Start: 2022-11-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2027-02-02
• Study Completion: 2027-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Patient willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on LFSPRO ShinyApp data	Through study completion, an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States