High Risk for Breast Cancer Clinical Trial
Official title:
Promoting Genetic Counseling Among African American Women With a Family History of Breast Cancer
In the United States, carriers of hereditary genetic mutations have up to an 85% risk of developing breast cancer compared to 12% in the general population. Overall uptake of genetic services is generally low, particularly among high-risk African American (AA) women, who carry a disproportionate burden of breast cancer mortality. Further, although testing close relatives of individuals who test positive for a pathogenic variant might curtail breast cancer disparities attributable to hereditary risk, it is unclear how counseled or tested individuals influence their social and familial networks. Using a randomized control trial design, the objective of this research project is to test the effectiveness of a culturally targeted video, previously developed by our research team, on promoting genetic counseling attendance among AA women determined to be at high risk for breast cancer through cancer genetic risk assessment in a clinical setting. This study will also test how psychosocial factors (knowledge, intrinsic motivation, risk perception, and distress) impact the relationships between intervention exposures (video versus brochure) and compare the impact of intervention exposures on diffusion of knowledge about genetic counseling through social network analysis.
Study Design. The investigator will conduct a randomized control trial single-blind control trial to test the effectiveness of a culturally targeted decision aid video to promote genetic counseling among African American determined to be high risk for breast cancer through cancer genetic risk assessment. Eligible patients will be randomly assigned to receive information about genetic counseling using a culturally targeted decision aid video (treatment group) or a brochure (control). Research Protocol. As part of standard of care, patients will complete a cancer genetic risk assessment (CGRA) as part of intake on a tablet computer provided by the front desk clinic staff. CGRA results will be uploaded to the EMR, printed and given to a patient navigator. The patient navigator will approach patients, give them a recruitment flyer, information about the study, screen patients and obtain informed consent for women who choose to participate in the study. Based on computer-generated randomization (equal numbers in each arm), patients will be randomized to one of two groups to receive: 1) pretest, view decision aid video, and posttest or 2) pretest, genetic counseling brochure, and posttest. Both arms will be facilitated by patient navigators. Upon completion of posttest, patient navigators will ask women if they would like to make an appointment for genetic counseling, contact the provider for the order if not already in the EMR, make genetic counseling appointments for women who choose to attend, and monitor and collect follow-up data. All enrolled participants will receive a phone call at 4 weeks post-intervention to (a) verify counseling attendance through self-report and EMR extraction if applicable; (b) ask whether the patient was referred to genetic testing after her genetic counseling if applicable; and (c) ask whether other family members were referred to genetic services if applicable and (d) determine who in their social networks, if anyone, the participant told about genetic counseling, and if so, how this information was shared. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00906321 -
Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
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N/A |