Clinical trial NCT04378751: Promoting Genetic Counseling Among African American Women With a Family History of Breast Cancer
Official title: Promoting Genetic Counseling Among African American Women With a Family History of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Risk for Breast Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-05-07
Enrollment: 106
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Computer-generated randomization (equal numbers in each arm), patients will be randomized to one of two arms:

1. Decision aid video
2. Genetic counseling informational brochure
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Are female
2. Identify as African American
3. Are age 25 or older
4. Speak and understand English
5. Completed a cancer genetic risk assessment (CGRA) as part of clinic intake
6. Are classified as high risk for developing breast cancer per CGRA
7. Have not previously received genetic counseling

Exclusion Criteria:

1. Are not female
2. Do not identify as African American
3. Are age 24 or younger
4. Do not speak and understand English
5. Did not complete a cancer genetic risk assessment (CGRA) as part of clinic intake
6. Are not classified as high risk for developing breast cancer per CGRA
7. Have previously received genetic counseling

Primary outcomes:
measure: Genetic Counseling Attendance
timeFrame: 52 weeks
Secondary outcomes:
measure: Decision Aid Usability
timeFrame: 52 weeks
measure: Knowledge about Genetic Counseling
timeFrame: 52 weeks
measure: Distress Associated with Genetic Counseling and Breast Cancer Risk
timeFrame: 52 weeks
measure: Intrinsic Motivation for Genetic Counseling Attendance
timeFrame: 52 weeks
measure: Risk Perception Associated with Breast Cancer
timeFrame: 52 weeks
measure: Diffusion of Knowledge
timeFrame: 56 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UIC Cancer Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago Hospital and Ambulatory Clinics
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Kent Hoskins, MD
role: PRINCIPAL_INVESTIGATOR
References: