Patient Navigation for Breast Cancer Risk Management

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Breast cancer, Ovarian cancer, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 months

75 Participants Needed

Trial Summary

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 data supports the effectiveness of the Patient Navigation Intervention treatment for breast cancer risk management?

Research shows that patient navigation helps women, especially those from underserved communities, receive timely and appropriate breast cancer care. It improves follow-up after abnormal mammograms and increases adherence to recommended treatments, leading to better health outcomes. ^{1 2 3 4 5}

Is patient navigation safe for humans?

The research on patient navigation for breast cancer care does not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 6 7 8}

How does the Patient Navigation Intervention treatment differ from other treatments for breast cancer risk management?

Patient Navigation Intervention is unique because it focuses on guiding patients through the healthcare system, helping them overcome barriers to timely care and improving access to necessary treatments, rather than directly treating the cancer itself. This approach is particularly beneficial for underserved populations, ensuring they receive timely follow-up and support throughout their cancer care journey. ^{1 2 6 9 10}

What is the purpose of this trial?

This clinical trial studies whether a patient navigation (PN) intervention can be used to improve risk management among women at high risk of breast cancer. Women with a family history of breast cancer have a higher lifetime risk of developing it. Risk management can benefit women at high risk of breast cancer and can include surveillance routines, preventative surgeries, and medications that can dramatically lower the risk of breast cancer and allow early detection. Although risk management can benefit women at high risk of breast cancer, only a small amount actually use it. PN is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN intervention in this study is designed to help give women the information and support they need to make choices about their breast cancer risk that they feel good about, which may improve risk management.

Research Team

Tasleem J Padamsee, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for women at high risk of breast cancer, often due to family history. It aims to help them manage their risk better through a patient navigation intervention that guides and supports them in making informed decisions about prevention and early detection strategies.

Inclusion Criteria

Non-Hispanic Black or non-Hispanic white

Have been identified as at potentially high risk by a population-based risk screening program

Are early in their risk-management adoption process, defined as currently identifying with stage 0 (never heard of it) or 1 (haven't decided) of the risk-management adoption pathway (R-MAP) in relation to at least one of the four risk-management actions recommended for all high-risk women: attending genetic counseling appointment, having a personalized risk assessment, undergoing annual clinical breast exams, and considering chemoprevention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive links to informational websites and monthly phone calls from a patient navigator for 8 months

8 months

8 visits (virtual)

Follow-up

Participants are monitored for satisfaction and information usage after the intervention

1 month

Treatment Details

Interventions

• Patient Navigation Intervention

Trial Overview The study tests if a patient navigation service can improve how high-risk women handle their breast cancer risks. This includes using telephone-based support, educational materials, and surveys to encourage participation in surveillance routines or preventative measures.

Participant Groups

Group I: Arm I (informational websites, PN) Experimental Treatment 4 Interventions

Participants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study.

Group II: Arm II (informational websites) Active Control 2 Interventions

Participants receive links to informational websites on breast cancer risk and risk management options on study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

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]

In a pilot study of 100 African American breast cancer patients, those who received patient navigation promoted breast cancer screening to more individuals in their social networks compared to those who did not receive navigation.

The study suggests that navigated patients not only increased awareness of breast cancer screening among their contacts but also potentially led to higher screening rates among their network members, indicating a broader impact of patient navigation on community health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigated African American breast cancer patients as incidental change agents in their family/friend networks. Molina, Y., Strayhorn, SM., Bergeron, NQ., et al.[2023]

Patient navigation (PN) was successfully implemented in resident clinics, leading to a significant increase in biennial screening mammography adherence among patients, particularly in vulnerable populations.

Residents expressed satisfaction with the PN process and showed interest in continuing its use, indicating that PN is a feasible and effective intervention in improving cancer screening rates in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of patient navigation in resident primary care practice: a screening mammography quality improvement initiative. Shroff, S., McCoy, ME., Sherman, BJ., et al.[2016]

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

The study analyzed patient navigator activities in 10 breast cancer navigation programs, revealing that individual-level tasks were consistently aligned with the published navigation model, emphasizing the importance of personalized support for patients.

However, there was significant variation in program-level principles, suggesting that factors like the use of volunteer versus clinical navigators influenced how closely programs adhered to the model, indicating a need for tailored guidance to meet community-specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of patient navigator activities in breast cancer patient navigation programs using a nine-principle framework. Gunn, CM., Clark, JA., Battaglia, TA., et al.[2021]

References

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

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

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Patient Navigation Program Improves Compliance With Adjuvant Breast Cancer Therapy in a Public Hospital. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Patient navigation for underserved patients diagnosed with breast cancer. [2021]

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

Can patient navigation improve receipt of recommended breast cancer care? Evidence from the National Patient Navigation Research Program. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Navigated African American breast cancer patients as incidental change agents in their family/friend networks. [2023]

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

Feasibility of patient navigation in resident primary care practice: a screening mammography quality improvement initiative. [2016]

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

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

Patient navigation and time to diagnostic resolution: results for a cluster randomized trial evaluating the efficacy of patient navigation among patients with breast cancer screening abnormalities, Tampa, FL. [2021]

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

An assessment of patient navigator activities in breast cancer patient navigation programs using a nine-principle framework. [2021]