Breast Cancer Clinical Trial
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Summary
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.
Full Description
PRIMARY OBJECTIVES:
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 versus telephone genetic counseling 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, and family communication.
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.
Eligibility Criteria
Inclusion Criteria:
Age 30 or older. Note: Participants must meet each of Criteria 1-4.
Have access to a healthcare provider and be willing to share genetic results with that provider
Have at least one ovary
Have a valid United States mailing address for receipt of saliva kit
Participants must meet any one of the following 6 criteria:
Diagnosed with breast cancer at age 45 or younger
Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 [Her2] amplified) breast cancer at 60 or younger
Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2
Have one relative with ovarian cancer
Have at least 2 relatives with breast cancer on the same side of the family, one of which is =< 50 years of age
Have one male relative with breast cancer
Exclusion Criteria:
Personal history of ovarian cancer
Unable to read, speak, and understand English
Unable to provide informed consent
Unwilling to complete baseline and follow-up questionnaires
Unable to access the internet
Previous genetic testing or counseling regarding cancer risk
Previous bone marrow transplant
Previous blood transfusion (7 days prior to genetic testing)
Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)
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