Community Service Navigation for Breast Cancer Screening

(B-SINCERE Trial)

Overseen By Elissa Ozanne, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Prior breast cancer

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding community service navigation to the usual process for addressing social needs can improve follow-up care after abnormal breast cancer screening results. It aims to determine if this approach enhances breast screening outcomes for women, particularly those with limited access to healthcare resources. The trial includes two groups: one receives standard referrals, while the other receives additional support from community service navigators who reach out via calls, texts, or emails. Women with abnormal mammogram results and at least one social need, such as housing or food support, are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve healthcare access and outcomes for women facing social challenges.

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

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

What prior data suggests that Community Service Navigation is safe for improving breast screening outcomes?

Research has shown that community service navigation is generally safe. This method helps patients, especially in underserved areas, receive necessary follow-up care after breast cancer screenings. Studies have found that patient navigation services, including community service navigation, remove obstacles to breast cancer screening without known health risks. This approach is well-tolerated and has no reported negative effects, making it a supportive option for improving health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Service Navigation for breast cancer screening because it offers a personalized approach to connecting patients with resources. Unlike the usual care, which relies on standard referrals, this method involves 211 Information Specialists reaching out directly to patients via their preferred communication method—phone, text, or email. This direct outreach and follow-up support aim to ensure that patients actually use the services they are referred to, potentially improving access and adherence to breast cancer screening recommendations. By focusing on patient preference and providing additional support, this approach could enhance screening participation and early detection rates.

What evidence suggests that Community Service Navigation is effective for improving breast screening outcomes?

Research has shown that community service navigation, which participants in this trial may receive, can improve breast cancer screening outcomes. These services assist women, particularly in underserved areas, in following up after abnormal screening results. For instance, one study found that even low-level navigation services helped women with noncancerous results obtain follow-up screenings. Another study demonstrated that community health workers significantly enhanced the quality of life for low-income, minority cancer patients. Overall, community navigation services help patients overcome barriers to necessary screenings, making them a promising approach to reducing healthcare inequalities. ^{3 4 6 7 8}

Who Is on the Research Team?

Elissa Ozanne, PhD

Principal Investigator

Huntsman Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women who are underserved and have had abnormal breast cancer screening results. It's designed to see if extra help from community services can improve follow-up care compared to the usual referral process.

Inclusion Criteria

Patients who have received an abnormal result of a screening mammogram

Patients who self-report at least one social need on the B-SINCERE Screener

Exclusion Criteria

I have been diagnosed with breast cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive community services navigation intervention in conjunction with social service referrals

18 months

Follow-up

Participants are monitored for the impact of the intervention on breast cancer screening episode completion and preventive care utilization

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Community Service Navigation

Trial Overview The study is testing whether adding a 'community services navigation' support helps women with abnormal breast cancer screenings better than the standard care they usually get, which might just be a simple referral.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Community Services Navigation with 211 Information Specialists (ISs) will conduct outreach to participants within 48 hours of referral through telephone, text, or email, depending on patient preference. Two weeks after initial contact ISs follow up with patients to provide additional support and document use of the referred services in ServicePoint.

Group II: Usual Care Active Control 1 Intervention

Standard referrals to community resources will be used for participants randomized to usual care.

Community Service Navigation is already approved in United States for the following indications:

Approved in United States as Patient Navigation Services for:

• Breast cancer screening disparities reduction
• Improvement in follow-up to abnormal breast cancer screening results

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Capital Breast Care Center (CBCC) in Washington, DC, has effectively increased mammography screening rates among medically underserved minority women through a community-based patient navigation program established between 2004 and 2015.

The integration of patient navigation with community engagement has led to strong partnerships with local organizations, enhancing access to breast cancer screening and education in a region with high breast cancer incidence and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community-Based Outreach Navigator Approach to Establishing Partnerships for a Safety Net Mammography Screening Center. Wallington, S., Oppong, B., Dash, C., et al.[2019]

A qualitative study involving 36 medically underserved cancer patients identified four key needs for effective patient navigation (PN) programs: improving access to quality care, addressing emotional and practical concerns, considering family issues, and supporting patients throughout their entire cancer journey from diagnosis to long-term survivorship.

Oncology social workers are positioned to play a crucial role in patient navigation, advocating for the inclusion of trained professionals to ensure that the specific needs of underserved cancer patients and their families are met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social workers as patient navigators for breast cancer survivors: what do African-American medically underserved women think of this idea? Davis, C., Darby, K., Likes, W., et al.[2022]

The Avon Foundation Community Patient Navigation Program successfully hosted 207 breast health events over 15 months, reaching 9,601 attendees and leading to 21% of participants completing mammograms, highlighting the program's effectiveness in increasing screening rates among Black women.

Participants who reported breast symptoms were twice as likely to receive a mammogram compared to those without symptoms, indicating that addressing health concerns can significantly motivate individuals to seek screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Avon Foundation community education and outreach initiative Community Patient Navigation Program. Mason, TA., Thompson, WW., Allen, D., et al.[2022]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

The development of a computer-mediated patient navigation platform aims to enhance cancer screening and follow-up in community settings, addressing the issue of underutilization of these services.

By improving access to cancer screening through this innovative tool, the project seeks to reduce disparities in cancer care and potentially lower mortality rates associated with late-stage diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing patient navigation electronic log (PaNEL): An innovative platform to facilitate cancer screening and detection. Lapshin, O., Castro, H., Ford, J., et al.[2016]

Patient navigation programs can significantly increase the rates of post-treatment surveillance mammography in women with breast cancer, suggesting a benefit in monitoring after treatment.

However, there is limited evidence that patient navigation improves treatment outcomes during breast cancer care, indicating a need for further research to fully understand its efficacy in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. Baik, SH., Gallo, LC., Wells, KJ.[2019]

Patient navigation (PN) significantly improves breast cancer screening completion rates, with an odds ratio of 2.0, indicating that those receiving navigation are twice as likely to complete screening compared to those who do not.

PN also reduces the time to diagnosis by an average of 9.9 days, enhancing the efficiency of the screening process, although it does not affect the resolution of abnormal test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Patient Navigation on Population-Based Breast Screening: a Systematic Review and Meta-analysis of Randomized Clinical Trials. Tian, L., Huang, L., Liu, J., et al.[2023]

A community-based program led by health workers effectively provides breast health education and navigation for women, addressing the gap in systematic support for initial screening mammograms.

The program highlights the importance of tailored navigation services to improve access to breast cancer screening, which is crucial for reducing racial disparities in breast cancer mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keys to the Successful Implementation of Community-Based Outreach and Navigation: Lessons from a Breast Health Navigation Program. Hunt, BR., Allgood, KL., Kanoon, JM., et al.[2022]

A patient navigation (PN) program significantly improved follow-up care for disadvantaged women with abnormal mammograms, with 90.4% receiving appropriate follow-up compared to 75.3% in practices without PN.

Women in the PN program also experienced quicker follow-up times, especially for BI-RADS 3 findings, where the likelihood of timely follow-up was more than double compared to non-PN practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. Percac-Lima, S., Ashburner, JM., McCarthy, AM., et al.[2018]

The Avon Foundation Community Education and Outreach Initiative's Patient Navigation Program was positively received by breast cancer patients, highlighting the strong relationships formed between patients and navigators, who were also breast cancer survivors.

While patients appreciated the navigators' support during appointments, they noted that the enrollment process could be improved, suggesting that enhancing this aspect could benefit similar programs across the US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of the Avon Foundation Community Education and Outreach Initiative Patient Navigation Program. Schlueter, DF., Thompson, WW., Mason, TA., et al.[2019]

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

The Boston Patient Navigation Research Program found that patient navigation significantly reduced the time to diagnosis for women with abnormal cervical cancer screenings (adjusted hazard ratio of 1.46) and for those with breast cancer screenings that resolved after 60 days (adjusted hazard ratio of 1.40).

The study involved 4,038 women across six community health centers, highlighting the effectiveness of patient navigation in improving timely diagnosis in a diverse inner-city population, which may help reduce cancer health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boston Patient Navigation Research Program: the impact of navigation on time to diagnostic resolution after abnormal cancer screening. Battaglia, TA., Bak, SM., Heeren, T., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5865251/

Patient Navigation Improves Subsequent Breast Cancer ... Our findings suggest that low-intensity navigation services can improve follow-up screening among women who receive a noncancerous result.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01723

Community Health Worker Navigation for Patients With ... Low-income minority patients with cancer randomly assigned to a community health worker intervention had significantly improved health related quality of life ...

3. thecommunityguide.org thecommunityguide.org/findings/cancer-screening-patient-navigation-services-to-increase-breast-cancer-screening.html

Breast Cancer Screening: Patient Navigation Patient navigation services provided through healthcare systems help patients overcome barriers to accessing breast cancer screening.

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-24372-x

Community navigation intervention for social needs in patients ... This study utilizes a 10-item social needs assessment and community navigation services to address social needs that prevent women from ...

5. womenspreventivehealth.org womenspreventivehealth.org/wp-content/uploads/Patient-Navigation-Evidence-Review-Nov-25-2024.pdf

Patient Navigation Services for Breast and Cervical Cancer ... Patient navigation services can be delivered by various types of healthcare professionals such as nurses, social workers, and community health ...

6. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rg.230090

Breast Cancer Disparity and Outcomes in Underserved ... Underserved women often experience significant delays in the diagnosis and treatment of breast cancer, leading to higher mortality rates.

7. datasharescc.org datasharescc.org/promisepractice/index/view?pid=30815

Cancer Screening: Patient Navigation Services to Increase ... Patient navigation services provided through healthcare systems help patients overcome barriers to accessing breast cancer screening. Services are offered ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5586005/

Use of Community Health Workers and Patient Navigators ... Our findings support the effectiveness of CHW/PN programs to improve completion and timeliness of breast, cervical, and colorectal cancer screening in FQHCs.