Patient Navigation for Timely Breast Cancer Diagnosis During COVID-19

Overseen By Anthony Keyes

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Unable to provide consent

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

Compensation: Varies

Number of Visits: Unknown

196 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.

What data supports the effectiveness of the treatment Patient Navigation for Timely Breast Cancer Diagnosis During COVID-19?

Research shows that patient navigation helps improve cancer outcomes by reducing barriers and ensuring timely access to care, which can lead to higher patient satisfaction and better coordination of care. ^{1 2 3 4 5}

Is patient navigation safe for humans?

Patient navigation, which helps coordinate healthcare and reduce barriers to treatment, has been used safely in cancer care to improve patient outcomes and satisfaction. There is no evidence suggesting it poses any safety risks to humans. ^{2 3 5 6 7}

How does patient navigation differ from other treatments for breast cancer diagnosis?

Patient navigation is unique because it focuses on guiding patients through the healthcare system to ensure timely diagnosis and treatment, especially during complex situations like the COVID-19 pandemic. Unlike traditional treatments that directly target the cancer itself, patient navigation addresses barriers to care, improving coordination and access to necessary medical services. ^{1 3 8 9 10}

What is the purpose of this trial?

The primary objective of this project is to evaluate the role of patient navigation in promoting timely follow-up of abnormal breast imaging findings in patient populations that have been most severely impacted by the novel coronavirus (COVID-19) pandemic. This project aims to assess the impact of patient navigation as an intervention tool in patient populations that are most at risk for delayed follow-up. The investigators hypothesize that patient navigation services may be an effective way to mitigate the impact of the pandemic by decreasing the risk of a delayed breast cancer diagnosis and promoting timely diagnostic follow-up.

Research Team

Eniola Oluyemi

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for patients with abnormal breast screening results during the COVID-19 pandemic who haven't had further diagnostic evaluation. It's aimed at those most affected by delays in follow-up due to the pandemic. Participants must be able to give consent.

Inclusion Criteria

My recent mammogram was abnormal, and I haven't had further tests yet.

Exclusion Criteria

Any study participant who is unable to provide consent to participate in the study will be excluded.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive patient navigation services to promote timely diagnostic follow-up

30 days

Telephone follow-ups as needed

Follow-up

Participants are monitored for diagnostic follow-up rates and anxiety levels

4 weeks

Treatment Details

Interventions

• Patient Navigation

Trial Overview The study is testing if patient navigator support can help people get timely follow-up care after an abnormal mammogram, especially during the disruptions caused by COVID-19. The goal is to see if this support reduces delays in diagnosing breast cancer.

Participant Groups

Group I: Usual care group Active Control 1 Intervention

The study participants in this group will receive the usual care per the institutional protocol.

Group II: Intervention group Active Control 1 Intervention

The study participants in this group will receive support from the patient navigator as part of this study.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Association of University Radiologists (AUR) - GERRAF

Collaborator

Trials

1

Recruited

200+

Findings from Research

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]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

The navigation program for cancer patients showed marginally lower rates of emergency room visits and unplanned hospitalizations among those who used the service, indicating some potential benefits in care coordination.

However, the program had low visibility and utilization among patients, and overall patient experiences were mixed, suggesting that a more focused approach may be needed to effectively support high-risk or anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. Winget, M., Holdsworth, L., Wang, S., et al.[2021]

Navigation programs in oncology significantly improve outcomes for cancer patients by reducing the time it takes to receive a diagnosis and treatment, while also enhancing knowledge and adherence to care among patients and caregivers.

These programs not only benefit patients but also healthcare institutions by lowering costs associated with emergency visits and readmissions, indicating a positive impact on overall healthcare efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the Oncology Nurse Navigator Throughout the Cancer Trajectory. [2019]

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 introduction of patient navigation for women directly referred for breast biopsies significantly reduced waiting times from 20 days in 1999 to 14 days in 2000, indicating improved efficiency in the diagnostic process.

Patient navigation not only enhances the timeliness of breast abnormality diagnoses but also has the potential to improve quality of life by providing quicker reassurance for benign conditions and facilitating earlier treatment for malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation: improving timeliness in the diagnosis of breast abnormalities. Psooy, BJ., Schreuer, D., Borgaonkar, J., 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]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

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

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. [2022]

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

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. [2021]

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

Role of the Oncology Nurse Navigator Throughout the Cancer Trajectory. [2019]

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

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

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

Patient navigation: improving timeliness in the diagnosis of breast abnormalities. [2022]

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

The evolution of breast cancer navigation and survivorship care. [2015]

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]