Patient Navigation for Breast Cancer

Overseen By Kathryn Glaser

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Previous cancer, Male sex, others

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

Compensation: Varies

Number of Visits: Unknown

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a patient navigation program designed to address disparities in breast cancer care. The program aims to boost patient knowledge, manage treatment barriers, and improve access to care. This could simplify breast cancer treatment management and enhance quality of life. Women recently diagnosed with breast cancer, who have not had cancer before, may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for patients to contribute to research that could improve breast cancer care for future patients.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on helping you navigate breast cancer care rather than changing your treatment plan.

What prior data suggests that this patient navigation program is safe for breast cancer patients?

Research has shown that patient navigation is a safe and helpful method in healthcare. Trained staff assist patients in overcoming obstacles to cancer care. Studies have found that patient navigation helps patients access screening, diagnosis, and follow-up care more easily.

No reports of negative effects exist because patient navigation does not involve medications or physical treatments. Instead, it focuses on offering guidance and support, making it a very safe option.

Overall, patient navigation is both safe and beneficial in helping people manage their cancer treatment and improve access to healthcare services. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Patient navigation is unique because it focuses on providing personalized guidance and support to breast cancer patients, rather than directly treating the cancer itself. Unlike standard treatments like surgery, chemotherapy, or radiation, which target the cancer cells, patient navigation helps patients understand their treatment options, access supportive care services, and overcome barriers to receiving care. Researchers are excited about this approach because it has the potential to improve patient outcomes by empowering individuals with the knowledge and resources they need to effectively manage their treatment journey.

What evidence suggests that this patient navigation program is effective for breast cancer care?

Research has shown that patient navigation programs, which participants in this trial will receive, can greatly improve breast cancer care. These programs increase the number of cancer screenings and follow-up appointments, essential for early detection and treatment. Patient navigation reduces delays in care, especially for those with limited access to healthcare, by providing support and guidance through the healthcare system. By helping patients understand medical information and access services, patient navigation can lead to better health outcomes for breast cancer patients. Overall, this approach has proven to improve the quality of cancer treatment and enhance patient experiences. ^{3 6 7 8 9}

Who Is on the Research Team?

Kathryn Glaser

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals assigned female at birth, currently identifying as women or female, aged 18 or older with a confirmed diagnosis of breast cancer or DCIS. They must understand the study's investigational nature and consent to participate without having had any previous cancer diagnoses.

Inclusion Criteria

Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention

I have been diagnosed with breast cancer or DCIS.

I have never been diagnosed with cancer before.

Exclusion Criteria

I was assigned male or intersex at birth.

Unwilling or unable to follow protocol requirements

I have been diagnosed with cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Patient Navigation Program

Participants receive patient navigation services to improve knowledge about clinical and supportive care services, navigate to existing services, manage barriers to care, and enhance skills related to management of cancer treatment

Up to 2 years

Follow-up

Participants are monitored for patient satisfaction, retention rate, barriers to care, use of supportive services, quality of life, and social determinants of health

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation

Trial Overview The trial evaluates a patient navigation program aimed at reducing disparities in breast cancer care. It focuses on improving patients' knowledge about clinical services, navigating healthcare systems, managing treatment barriers, and enhancing skills for handling their cancer treatment.

How Is the Trial Designed?

Group I: Health Services Research (Patient Navigation) Experimental Treatment 2 Interventions

Patients receive patient navigation services from a patient navigator as needed to improve knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance skills related to management of cancer treatment

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

A study assessing patient navigation programs at six Boston hospitals revealed significant variability in how these programs are structured and implemented, affecting their effectiveness in supporting breast cancer patients.

Despite all hospitals offering navigation services, inconsistencies in funding, targeted patient populations, and the continuity of services highlight critical gaps that could be addressed to improve care and reduce disparities in breast cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of patient navigation programs for breast cancer patients across the city of Boston. LeClair, AM., Battaglia, TA., Casanova, NL., 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]

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 implementation of a breast cancer navigation (BCN) program significantly improved the timeliness of biopsy result disclosures and initial consultations for patients, enhancing overall patient care coordination.

Patients experienced fewer outpatient visits and increased referrals to cancer specialists within a month of biopsy, indicating more efficient use of healthcare resources and better management of their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lean Practices for Resource Use, Timeliness, and Coordination of Care in Breast Cancer Navigation. Hung, DY., Kim, P., Li, M., et al.[2022]

Patient navigation (PN) significantly increases patient satisfaction with cancer care according to a randomized controlled trial, showing a large effect size (SMD = 2.30), indicating its potential effectiveness in improving patient experiences.

However, non-randomized studies did not find a significant association between PN and satisfaction, suggesting that the quality of the study design may influence the perceived effectiveness of PN in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of patient navigation on satisfaction with cancer care: a systematic review and meta-analysis. Wells, KJ., Campbell, K., Kumar, A., et al.[2019]

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 study involving 1345 patients with abnormal cancer screenings or cancer diagnoses found a significant correlation between satisfaction with patient navigators and overall satisfaction with cancer-related care, indicating that effective navigation can enhance patient experiences.

Factors such as having an abnormal colorectal cancer screening and being older or from a minority racial-ethnic background were linked to higher satisfaction levels, suggesting that tailored navigation support may help address disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. Jean-Pierre, P., Cheng, Y., Wells, KJ., et al.[2022]

The implementation of a patient navigator program at a public hospital significantly improved adherence to breast cancer quality care indicators from 69% to 86% among 100 newly diagnosed patients (Stages I to III).

The program particularly enhanced the use of surveillance mammography, increasing adherence from 52% to 76%, demonstrating that patient navigators can effectively address barriers to care in uninsured populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving breast cancer quality of care with the use of patient navigators. Chen, F., Mercado, C., Yermilov, I., et al.[2010]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

In a study of 438 cancer patients, patient navigation (PN) did not significantly improve overall treatment completion time, satisfaction with care, or psychological distress compared to usual care.

However, socially disadvantaged patients who received PN reported higher satisfaction with their care, indicating that PN may be beneficial for specific groups, despite no overall benefits observed in the primary analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for breast and colorectal cancer treatment: a randomized trial. Fiscella, K., Whitley, E., Hendren, S., et al.[2021]

Oncology nurse navigation programs significantly reduced the time from the first provider visit to the start of therapy for patients with hematologic malignancies, improving access to care.

Patient and provider satisfaction scores were high regarding the navigation program, although it did not lead to an increase in clinical trial enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . Gordils-Perez, J., Schneider, SM., Gabel, M., et al.[2018]

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. 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 are provided by healthcare systems to help patients overcome barriers to cancer screening and follow-up as they move ...

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

Patient Navigation Improves Rates of Cancer Screening ... A systematic review showed that patient navigation services led to increases in rates of breast cancer screening and follow-up and cervical ...

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

Cost and activity analysis for a citywide patient navigation ... Patient navigation is an evidence-based intervention for reducing delays in cancer care for underserved populations.

5. bu.edu bu.edu/articles/2017/patient-navigators/

Patient Navigators Improve Outcomes for Breast Cancer ... “We've demonstrated improvements in screening rates, we've demonstrated reductions in times of diagnosis, we've also demonstrated reductions in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8462600/

Systematic Patient Navigation Strategies to Scale Breast ... Patient navigation uses trained personnel to eliminate barriers to timely care across all phases of the health care continuum, thereby reducing health ...

7. cdc.gov cdc.gov/cancer/php/interventions/patient-navigation.html

Patient Navigation | Cancer Patient navigators work with people, their families, and their caregivers to overcome barriers to cancer screening and diagnosis, cancer care, and resources ...

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

Patient navigation across the cancer care continuum: An ... Patient navigation is a strategy for overcoming barriers to reduce disparities and to improve access and outcomes. The aim of this umbrella ...

9. ascopubs.org ascopubs.org/doi/10.1200/jco.2009.27.15_suppl.6572

Impact of patient navigation on breast cancer outcomes One potential impact of PN program was dramatic increase in proportion of insured patients. Overall survival was not influenced by the PN program. Conclusions: ...