Genetic Counseling Support for Breast Cancer

Recruiting at 1 trial location

Overseen By Kent Hoskins, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Not female, Not African American, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

106 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kent Hoskins, MD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for African American women aged 25 or older who have been identified as high risk for breast cancer through a genetic risk assessment and have not previously received genetic counseling. Participants must speak and understand English.

Inclusion Criteria

Completed a cancer genetic risk assessment (CGRA) as part of clinic intake

I am 25 years old or older.

I am female.

Exclusion Criteria

I have undergone genetic counseling.

Do not identify as African American

I am not female.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants are randomized to receive either a decision aid video or a genetic counseling brochure, followed by pretest and posttest assessments

Immediate

1 visit (in-person)

Follow-up

Participants receive a phone call at 4 weeks post-intervention to verify counseling attendance and assess diffusion of knowledge

4 weeks

1 call (virtual)

Long-term Follow-up

Participants are monitored for changes in knowledge, motivation, and distress related to genetic counseling over a 52-week period

52 weeks

Treatment Details

Interventions

• Decision aid video
• Genetic counseling informational brochure

Trial Overview The study is testing the effectiveness of a culturally targeted video versus an informational brochure in encouraging attendance at genetic counseling sessions among high-risk African American women.

Participant Groups

Group I: Decision aid video Experimental Treatment 1 Intervention

Participants receiving the intervention will complete a pretest, watch the decision aid video, and complete posttest via tablet computer facilitated by Patient Navigators.

Group II: Genetic counseling informational brochure Active Control 1 Intervention

Participants receiving the control will complete pretest, review a genetic counseling brochure with the Patient Navigators, and complete posttest via tablet computer facilitated by a Patient Navigator.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+