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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women at high risk of breast cancer manage their risk more effectively. It tests a service called Patient Navigation (PN), which provides guidance and support for making informed choices about breast cancer risk management. Participants will either receive phone calls from a patient navigator along with access to informational websites or access to the websites alone. Women with a family history of breast cancer who have not yet started risk-management actions, such as genetic counseling or regular breast exams, may be well-suited for this study. As an unphased trial, this study offers participants a unique opportunity to gain personalized support and information to proactively manage their breast cancer risk.

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 patient navigation intervention is safe for breast cancer risk management?

Research has shown that patient navigation (PN) programs are generally safe and well-received. These programs assist women with breast cancer by guiding them through the healthcare system, facilitating timely care and support.

The research has not identified any specific safety issues or negative effects related to patient navigation. As a supportive service, not a medication or surgery, PN does not carry the same risks as those treatments.

Overall, patient navigation is considered a helpful and safe method to enhance breast cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how patient navigation can enhance breast cancer risk management. Unlike traditional approaches that rely solely on informational resources, this method provides personalized support through regular phone calls with a patient navigator. This interaction ensures that participants not only receive information but also have ongoing guidance to understand and manage their breast cancer risk more effectively. By combining educational resources with personalized support, this approach aims to empower individuals to make informed health decisions, potentially improving outcomes compared to standard informational methods.

What evidence suggests that the Patient Navigation intervention is effective for breast cancer risk management?

Research has shown that a patient navigator can greatly improve breast cancer risk management. In this trial, one group of participants will receive both informational websites and support from a patient navigator, while another group will receive only informational websites. Studies have found that patient navigation increases breast cancer screening rates by 13.8% compared to just providing information. Another study found that these programs make individuals 32% more likely to get screened. Patient navigators guide patients through the healthcare system, ensuring they complete important screenings and follow-up care. By offering support and reducing obstacles, patient navigation can lead to better outcomes for women at high risk of breast cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Tasleem J Padamsee, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06950008

A Patient Navigation Intervention for the Improvement of ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9561367/

Patient Navigation Can Improve Breast Cancer Outcomes ... Simulation results suggest that network navigation may lead up to a 13% increase in screening completion rate, 7.8% increase in diagnostic ...

3. hematologyadvisor.com hematologyadvisor.com/news/patient-navigation-improves-rates-cancer-screening-follow-up/

Patient Navigation Improves Rates of Cancer Screening ... The predicted 1-year absolute breast cancer screening rate was estimated to be 13.8% higher with patient navigation, in comparison with use of ...

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

Breast Cancer Screening: Patient Navigation Patient navigation interventions increased breast cancer screening. ... Meta-analysis: risk ratio of 1.32, 95% CI 1.08 to 1.62 (10 studies). When compared with ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35671

Cost and activity analysis for a citywide patient navigation ... This study presents findings from a cost and activity analysis of a citywide hospital-based patient navigation program to engage women in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5065113/

Patient Navigation in Breast Cancer Treatment and ... This systematic review evaluates the efficacy of patient navigation in improving treatment and survivorship outcomes in women with breast cancer.

7. jcancer.org jcancer.org/v02p0467.htm

Impact of Patient Navigation from Diagnosis to Treatment in ... Conclusions: Navigation program did not influence the stage of presentation or the overall survival of women. There was a modest decrease in the time between ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Overall evidence from 43 unique primary studies across nine reviews suggested that patient navigation interventions were effective at reducing ...