Decision Support for Breast Cancer Screening

Overseen By Claire C. Conley, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Age, Pregnancy

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

Compensation: Varies

Number of Visits: 3

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help women make informed choices about breast MRI screenings. It compares two approaches: one group receives a risk assessment and nurse referral, while the other also receives an additional decision aid to better understand options. The trial seeks Black and Latina women who have a high lifetime risk of breast cancer, have had normal mammogram results in the past year, and speak English or Spanish. The goal is to determine if these tools assist women in making better-informed health decisions. As an unphased trial, this study offers participants the chance to contribute to research that could improve decision-making tools for breast cancer screenings.

Will I have to stop taking my current medications?

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

What prior data suggests that this decision support intervention is safe for breast cancer screening?

Research has shown that decision support tools, like the one tested in this trial, are generally safe and easy to use. These tools help people make informed choices about breast cancer screening without involving medication or medical procedures, eliminating concerns about physical side effects.

Previous studies have demonstrated that decision support aids in understanding complex information without causing harm. Since this trial does not involve a new drug or invasive treatment, the risk of negative effects remains low. The main goal is to provide clear information to help participants make informed decisions about breast cancer screening.

Overall, decision support tools are expected to be safe for participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance decision-making for breast cancer screening through innovative support tools. Unlike standard care, which typically involves routine information sharing about breast cancer risks, the "Decision Support" treatment goes a step further by including a personalized decision aid sent via mail or email. This approach could empower individuals with tailored guidance, potentially improving their understanding and decision-making regarding their screening options. The trial hopes to uncover whether these additional resources can lead to more informed choices and better outcomes for those at risk of breast cancer.

What evidence suggests that this trial's treatments could be effective for informed decisions about breast MRI?

This trial will compare Decision Support with Enhanced Usual Care for breast cancer screening. Studies have shown that decision-making tools can improve understanding of choices in breast cancer screening. Research indicates that providing extra information and guidance increases confidence in screening decisions. For example, these tools explain personal risk and outline the benefits and risks of screenings like breast MRI. Although these tools don't directly lower cancer rates, they help individuals make choices that align with their health needs and preferences. Overall, decision support aims to simplify complex information and assist in making informed health decisions. ^{1 2 3 4 6}

Who Is on the Research Team?

Claire C. Conley, PhD

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

This trial is for high-risk Black and Latina women aged 40-74, who speak English or Spanish, have no personal history of breast cancer, received a mammogram through RLC navigation, and have a ≥20% lifetime risk per the NCI BCRAT.

Inclusion Criteria

I received a mammogram via the Ralph Lauren Center.

My risk of breast cancer over my lifetime is 20% or higher.

I identify as Black and/or Latina.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (phone)

Baseline Assessment

Participants complete baseline assessment and are randomized to intervention arms

1 week

1 visit (phone or in-person)

Intervention

Participants receive either enhanced usual care or decision support intervention

1 month

Materials sent via mail or email

Follow-up

Participants are monitored for informed decision-making and decision satisfaction

1 month

1 visit (phone or in-person)

Extended Follow-up

Receipt of MRI assessed via EMR review

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Decision Support
• Enhanced Usual Care

Trial Overview The study tests if a decision support intervention helps these women make informed choices about breast MRI screening. It compares enhanced usual care with added decision aid against just enhanced usual care.

How Is the Trial Designed?

Group I: Decision Support Experimental Treatment 2 Interventions

Participants in this arm will receive the same letter as those in the Enhanced Usual Care arm. In addition, they will be sent the decision aid via mail or email (as preferred).

Group II: Enhanced Usual Care Active Control 1 Intervention

Participants in this arm will be mailed a letter with their estimated lifetime risk for breast cancer per the NCI Breast Cancer Risk Assessment Tool (BCRAT), information about screening breast MRI, and instructions for contacting the nurse practitioner (NP) at the Ralph Lauren Center (RLC) with questions.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38687505/

A Decision Analysis for the US Preventive Services Task Force Biennial DBT screening at age 40 to 74 years (vs no screening) was associated with a 30.0% breast cancer mortality reduction, 1376 false- ...

2. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.232658

Outcomes of Breast Cancer Screening Strategies Based on ... Annual screening ages 40–79 years averted the most breast cancer deaths (11.5 per 1000) and gained the most life-years (230 per 1000) compared ...

3. nature.com nature.com/articles/s41591-024-03408-6

Nationwide real-world implementation of AI for cancer ... Radiologists in the AI-supported screening group achieved a breast cancer detection rate of 6.7 per 1,000, which was 17.6% (95% confidence ...

4. pcori.org pcori.org/research-results/2016/comparing-effectiveness-breast-cancer-screening-and-diagnostic-tests-among-women-different-breast-densities-bcsc-advance-study

Comparing the Effectiveness of Breast Cancer Screening ... What were the results? · Higher benefits · Higher harms · No difference in failures · More confidence in screening · More worry about cancer.

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2818284

Screening for Breast Cancer: Evidence Report and ... Meta-analysis of 3 large trials did not show a statistically significant difference in rates of interval cancer after screening with DBT ...

6. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(24)00267-X/fulltext

Screening performance and characteristics of breast ... Standard screening among 52 872 participants resulted in 262 detected cancers and 1027 recalls. Cancer-detection rates were 6·4 per 1000 (95% CI ...