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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05126810

Enrollment

500

Registered

2021-11-19

Start date

2022-11-03

Completion date

2027-10-02

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Li-Fraumeni Syndrome

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.

Interventions

OTHERQuestionnaire Administration

Complete questionnaire

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Contacts

CONTACTBanu Arun

barun@mdanderson.org713-792-2360

PRINCIPAL_INVESTIGATORBanu Arun

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026