Evaluating willingness to participate in genetic counseling comparison
Evaluate Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling Based on LFSPRO-ShinyApp Data
This study is trying to see how willing people with Li-Fraumeni syndrome are to join a future trial comparing regular genetic counseling to personalized genetic counseling.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05126810 on ClinicalTrials.gov |
What this trial studies
This observational study assesses patients' willingness to participate in a future trial that compares standard genetic counseling with personalized genetic counseling for individuals affected by Li-Fraumeni syndrome. Participants will complete a questionnaire that takes approximately 15-20 minutes, with additional questions for those who test positive for a TP53 mutation. The goal is to gather insights on patient preferences and motivations regarding genetic counseling options, which may inform future research designs.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 15 or older who are receiving genetic counseling for TP53 genetic testing or have a confirmed TP53 germline mutation.
Not a fit: Patients who are non-English speaking or have a low suspicion for a TP53 mutation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of patient preferences in genetic counseling, leading to improved counseling approaches.
How similar studies have performed: While this approach is focused on patient willingness, similar studies have shown success in understanding patient preferences in genetic counseling.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Banu Arun — M.D. Anderson Cancer Center
- Study coordinator: Banu Arun
- Email: barun@mdanderson.org
- Phone: 713-792-2360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.