Genetic Counseling Support for Breast Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a culturally targeted video can encourage African American women at high risk for breast cancer to attend genetic counseling. Participants will either watch this decision aid video or review an informational brochure about genetic counseling. The goal is to identify which method better promotes genetic counseling and how these tools spread knowledge within personal networks. Women labeled high-risk for breast cancer after a genetic risk assessment, who identify as African American and have not yet had genetic counseling, might be a good fit for this trial.

As an unphased trial, this study offers a unique opportunity to contribute to research that could improve health communication strategies for high-risk communities.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this genetic counseling support method is safe?

Research shows that decision aid videos, like the one being tested, are generally safe and easy to use. In past studies, similar videos have helped people understand breast cancer and genetic testing without causing harm. Participants found these videos helpful for learning and decision-making.

The genetic counseling informational brochure is also safe. It serves as a standard educational tool, used in healthcare for a long time to provide information.

Overall, both the decision aid video and the brochure offer safe ways to learn about genetic counseling. They are designed to help people make informed health choices without any physical risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative ways to support decision-making in breast cancer genetic counseling. Unlike traditional brochures, the decision aid video offers an interactive and engaging way to understand complex genetic information, potentially making it easier for patients to grasp their options. Meanwhile, the genetic counseling informational brochure serves as a reliable, straightforward resource that may help reinforce key information. By comparing these two approaches, the trial aims to identify which method better supports patients in understanding their genetic risks and making informed choices about their health.

What evidence suggests that this trial's treatments could be effective for promoting genetic counseling attendance among high-risk African American women?

Research has shown that videos designed to aid decision-making can encourage more people, particularly in high-risk groups, to seek genetic counseling. In this trial, participants in one arm will watch a decision aid video. One study found that a culturally tailored video increased the number of Black women at risk for breast cancer who pursued genetic counseling. Another study demonstrated that educational videos might boost genetic testing for various cancers, including breast cancer. These videos clarify the pros and cons of genetic testing and counseling, increasing participation. Overall, decision aid videos offer a promising method to raise awareness and encourage action regarding genetic counseling. ^{1 5 6 7 8}

Who Is on the Research Team?

Kent Hoskins, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1237120/

Effect of a Computer-Based Decision Aid on Knowledge, ... It is an interactive, multimedia CD-ROM–based decision aid designed to educate women about breast cancer, heredity, and the benefits and limitations of genetic ...

2. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-08193-x

Pilot study of a culturally sensitive intervention to promote ... Our team developed a culturally sensitive, narrative decision aid video to promote uptake of genetic counseling among Black women at risk ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00809

Results From a Randomized Study | JCO Oncology Practice This paper shows that VE is a viable option, which may increase GT uptake for patients with breast, ovarian, pancreatic, or metastatic prostate cancer.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098360025002205

Implementing interventions to increase genetic testing for ... To systematically review the implementation strategies, outcomes, and quality of interventions aimed at increasing the uptake of breast cancer-related genetic ...

5. gimjournal.org gimjournal.org/article/S1098-3600(25)00071-1/abstract

Outcomes and effectiveness of decision aids for families ... Most DAs targeted women (69.6%) with hereditary breast and ovarian cancer syndrome (73.9%) in North America and Europe (81.3%), primarily ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9233847/

Pilot study of a culturally sensitive intervention to promote ... Our team developed a culturally sensitive, narrative decision aid video to promote uptake of genetic counseling among Black women at risk for a hereditary ...

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13408-x

The breast cancer genetic testing experience: probing the ... The breast cancer genetic testing experience: probing the potential utility of an online decision aid in risk perception and decision making.

8. sciencedirect.com sciencedirect.com/science/article/pii/S109836002103447X

Evaluation of a decision aid for families considering p53 ... We evaluated outcomes following the administration of a video-based decision aid (DA) prior to clinical p53 genetic counseling and testing among persons who had ...