Breast Cancer Clinical Trial
Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers
Summary
This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.
Full 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
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:
Pregnant
Prisoners
Inability to understand English as a spoken language in a healthcare context
Known hematologic malignancy (e.g. CLL)
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There are 6 Locations for this study
Boston Massachusetts, 02215, United States
Brighton Massachusetts, 02135, United States
Milford Massachusetts, 01757, United States
Weymouth Massachusetts, 02190, United States
Londonderry New Hampshire, 03053, United States
Providence Rhode Island, 02903, United States
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