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

Li-Fraumeni Syndrome Clinical Trial

Official title:

Evaluate Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling Based on LFSPRO-ShinyApp Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05126810
• Other study ID #: 2021-0151
• Secondary ID: NCI-2021-1071620
• Status: Recruiting
• Start date: November 3, 2022
• Est. completion date: October 2, 2027

Study information

• Verified date: October 2023
• Source: M.D. Anderson Cancer Center
• Contact: Banu Arun
• Phone: 713-792-2360
• Email: barun[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Li-Fraumeni Syndrome

Intervention

Other:
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M.D. Anderson Cancer Center