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

Trial Summary

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 data supports the effectiveness of the treatment Community Service Navigation for Breast Cancer Screening?

Research shows that patient navigation programs, which help guide patients through the healthcare system, can improve follow-up care after abnormal mammograms and enhance satisfaction with cancer screening, especially in underserved communities. These programs often address barriers to care and provide emotional and practical support, which can lead to better health outcomes. ^{1 2 3 4 5}

Is Community Service Navigation safe for humans?

The research does not specifically mention any safety concerns related to Community Service Navigation or similar programs, suggesting it is generally considered safe for humans. ^{1 2 6 7 8}

How is the Community Service Navigation treatment different from other breast cancer screening treatments?

Community Service Navigation is unique because it involves community health workers who guide and support individuals through the breast cancer screening process, focusing on education and overcoming barriers to access, rather than traditional medical interventions. ^{8 9 10 11 12}

What is the purpose of this trial?

The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.

Research Team

Elissa Ozanne, PhD

Principal Investigator

Huntsman Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of the Avon Foundation Community Education and Outreach Initiative Patient Navigation Program. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of Patient Navigation on Population-Based Breast Screening: a Systematic Review and Meta-analysis of Randomized Clinical Trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Boston Patient Navigation Research Program: the impact of navigation on time to diagnostic resolution after abnormal cancer screening. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Keys to the Successful Implementation of Community-Based Outreach and Navigation: Lessons from a Breast Health Navigation Program. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Introducing patient navigation electronic log (PaNEL): An innovative platform to facilitate cancer screening and detection. [2016]

11. England pubmed.ncbi.nlm.nih.gov

A Community-Based Outreach Navigator Approach to Establishing Partnerships for a Safety Net Mammography Screening Center. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Avon Foundation community education and outreach initiative Community Patient Navigation Program. [2022]