Clincosm LogoSign in Get a demo

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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05126810
Collaborator
National Cancer Institute (NCI) (NIH)
500
Enrollment
1
Location
14.9
Anticipated Duration (Months)
33.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluate Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling Based on LFSPRO-ShinyApp Data
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Observational (questionnaire)

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.

Other: Questionnaire Administration
Complete questionnaire

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Banu Arun, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05126810
Other Study ID Numbers:
  • 2021-0151
  • NCI-2021-10716
  • 2021-0151
First Posted:
Nov 19, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Additional relevant MeSH terms:
Li-Fraumeni Syndrome

Study Results

No Results Posted as of May 6, 2022