Online Genetics Educational Video with or without Pre- and / or Post-Telephone Genetics Counseling in Assessing Cancer-Risk Distress in Patients with Triple Negative Breast Cancer
- 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
- Diagnosed with breast cancer at age 45 or younger. Note: Participants must also meet any one of Criteria 5-10
- 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
- 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)
I. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.
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.
Trial Phase Phase NA
Trial Type Screening
M D Anderson Cancer Center
Karen H. Lu
- Primary ID 2016-0298
- Secondary IDs NCI-2017-01600
- Clinicaltrials.gov ID NCT02993068