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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04378751.
Locations matching your search criteria
United States
Illinois
Chicago
University of IllinoisStatus: Active
Contact: Vida Henderson
Phone: 312-413-7455
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.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Illinois
