Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers - GeneBOPP
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 269
- Locations
- 6
- Primary Endpoint
- Rate of patients who have germline genetic tests
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.
Detailed Description
This prospective, randomized controlled trial will evaluate the effect of two pre-test education methods on the level of participation in genetic testing for hereditary cancer risk. A prospective study examines outcomes before the development of a disease. * The research study procedures include screening for eligibility, randomization and a series of questionnaires. * Participants will be randomized, or assigned by chance, to one of two methods of pre-genetic test education and after completing either pre-test education participants will be offered the opportunity to have genetic testing performed Two methods of pre-genetic test education: * video education * in-person counseling * Genetic testing will be performed by blood draw. * It is expected that 500 people will participate in this study * Participants will be in the research study for up to 5 yrs after enrollment
Investigators
Huma Rana, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Potentially eligible participants will be identified via medical record screening and/or in accordance with their clinical visit. A HIPAA waiver of authorization will be obtained by the enrolling Institution as needed to have access to the subject's medical record information for screening of eligibility.
- •A member of the study team will approach the potentially eligible participant in clinic and discuss the trial. Potentially eligible participants may choose to discuss participation further with their physician at their appointment
- •Age ≥ 18 years
- •Breast, ovarian, pancreatic, or metastatic prostate cancer
- •No prior cancer genetic testing
- •Ability to understand and the willingness to sign an informed consent document
Exclusion Criteria
- •Prisoners
- •Inability to understand English as a spoken language in a healthcare context
- •Known hematologic malignancy (e.g. CLL)
Outcomes
Primary Outcomes
Rate of patients who have germline genetic tests
Time Frame: Up to 3 years
Measurement of genetic testing uptake in breast, ovarian, pancreatic, and prostate cancer patients randomized to pre-genetic test (pre-test) in-person counseling with a genetic counselor per standard of care or video education.This comparison will use a two-sided Fisher exact test
Secondary Outcomes
- Patient Satisfaction Survey following intervention(Immediately following intervention)
- Cascade testing in positives(after results have been received, four months post-intervention)
- Decisional Regret(after results have been received, two months post-intervention)
- Result Disclosure Preference following intervention(Immediately following intervention)
- Knowledge about genetics testing(Immediately following intervention)
- Patient Satisfaction 2 months following intervention(after results have been received, two months post-intervention)
- Psychological distress following intervention(after results have been received, two months post-intervention)
- Family communication of genetic test results(after results have been received, two months post-intervention)
- Positive Results impact(after results have been received, four months post-intervention)