This randomized clinical trial studies how well online genetics educational video with or without pre- and/or post-telephone genetics counseling works in assessing cancer-risk distress in patients with triple negative breast cancer. Online genetic education and telephone genetic counseling may help the doctors learn the stress a person feels about their risk of cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02993068.
PRIMARY OBJECTIVE:
I. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.
SECONDARY OBJECTIVES:
I. To test the effects of online genetic education alone versus telephone genetic counseling with online genetic education on testing completion rates.
II. To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.
III. To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing.
IV. To examine the cancer screening and prevention behaviors, as well as cascade testing behaviors among patients who tested positive for a pathogenic variant.
V. To determine factors contributing to non-completion of genetic testing in subjects enrolled in a genetic testing trial.
VI. To determine the impact of pre- and/or post-test genetic counseling on family communication, genetic testing concerns and screening behaviors.
OUTLINE: Patients are randomized into 1 of 4 arms.
ARM A: Patients watch genetic testing online educational video and receive genetic testing online test results report.
ARM B: Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
ARM C: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
ARM D: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorRoni Nitecki Wilke