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

Trial Summary

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 data supports the effectiveness of the treatment Patient Navigation for Breast Cancer?

Research shows that patient navigation helps improve the quality of breast cancer care by increasing adherence to treatment guidelines and enhancing patient satisfaction. It also aids in timely follow-up care, especially for disadvantaged women, by reducing barriers to accessing healthcare. ^{1 2 3 4 5}

Is patient navigation safe for humans?

The available research does not specifically address the safety of patient navigation, but it is generally considered a supportive service that helps coordinate care and improve patient satisfaction, suggesting it is safe for use in humans. ^{2 3 6 7 8}

How is the treatment Patient Navigation for Breast Cancer different from other treatments?

Patient Navigation for Breast Cancer is unique because it focuses on helping patients overcome barriers to care by coordinating healthcare services and ensuring timely access to treatment, rather than directly treating the cancer itself. This approach is particularly beneficial for underserved communities, improving satisfaction and outcomes by making the healthcare process more patient-centered and accessible. ^{2 4 9 10 11}

What is the purpose of this trial?

This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.

Research Team

Kathryn Glaser

Principal Investigator

Roswell Park Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of patient navigation on satisfaction with cancer care: a systematic review and meta-analysis. [2019]

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

Improving breast cancer quality of care with the use of patient navigators. [2010]

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

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

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 for breast and colorectal cancer treatment: a randomized trial. [2021]

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

Lean Practices for Resource Use, Timeliness, and Coordination of Care in Breast Cancer Navigation. [2022]

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

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Assessment of patient navigation programs for breast cancer patients across the city of Boston. [2022]