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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether patient navigation can expedite follow-ups after an unusual mammogram finding. The aim is to determine if additional support can prevent delays in diagnosing breast cancer, particularly during the challenges of COVID-19. The trial includes two groups: one receives regular care, and the other receives assistance from a patient navigator, a healthcare professional who guides patients through the healthcare system. Individuals who have had an abnormal mammogram but have not yet undergone further tests might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance patient care and support systems.

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 prior data suggests that patient navigation is safe for promoting timely breast cancer diagnosis?

Research has shown that patient navigation safely and effectively improves cancer care. Studies have found that it helps patients overcome obstacles to obtaining the right screenings and follow-up care, especially in complicated healthcare systems. No reports of serious side effects have emerged from using patient navigation. Designed to support patients, it ensures they receive timely medical attention, crucial for early cancer detection and treatment. Overall, patient navigation is well-received and plays an important role in healthcare strategies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about patient navigation for breast cancer diagnosis because it offers personalized support, which is especially crucial during the disruptions caused by COVID-19. Unlike standard care, which typically involves routine medical follow-ups, patient navigation provides individuals with a dedicated guide to help them navigate the healthcare system, ensuring timely appointments and reducing barriers to care. This approach can potentially lead to faster diagnoses and better health outcomes, which is critical when delays can significantly impact prognosis.

What evidence suggests that patient navigation is effective for timely breast cancer diagnosis?

Research has shown that patient navigation, which participants in the intervention group of this trial will receive, can ensure timely follow-up for breast cancer diagnosis, especially during the COVID-19 pandemic. Patient navigation offers personalized support to guide patients through complex healthcare systems, helping them receive prompt care. Studies indicate that these programs can reduce delays in breast imaging and diagnosis, crucial for effective treatment. In places like Botswana, patient navigation has played a vital role in improving cancer care, leading to better early detection and treatment coordination. Overall, patient navigation shows promise in promoting quicker access to necessary tests and care. ^{5 6 7 8 9}

Who Is on the Research Team?

Eniola Oluyemi

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05181722

Evaluating the Use of Patient Navigation to Promote Timely ... 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 ...

2. researchgate.net researchgate.net/publication/368345450_Impact_of_Patient_Navigation_on_Reducing_Breast_Imaging_Disparities_and_Applications_in_the_COVID-19_Era

Impact of Patient Navigation on Reducing Breast Imaging ... Patient navigation programs can serve as a key part of the strategy to mitigate the impact of the COVID-19 pandemic on timely breast cancer diagnosis. These ...

3. who.int who.int/publications/i/item/9789240100954

Patient navigation for early detection, diagnosis and ... Patient navigation is an evidence-based personalised intervention designed to guide patients through often complex cancer care systems to receive timely care.

4. globalhealth.rutgers.edu globalhealth.rutgers.edu/uncategorized/patient-navigation-critical-for-survival-in-breast-cancer-treatment-training-expanded-in-botswana/

Patient Navigation Critical for Survival in Breast Cancer ... Initiative helps close critical gaps in cancer care, improving early detection and treatment coordination across Botswana.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11695749/

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 timely breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063100/

Patient Navigation in Cancer Treatment: A Systematic Review The findings suggest that patient navigation plays a crucial role in improving access to care and optimizing treatment outcomes, especially for disadvantaged ...

7. 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 ...

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

Breast Cancer Screening: Patient Navigation Patient navigation services provided through healthcare systems help patients overcome barriers to accessing breast cancer screening. Services are offered ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3171897/

Impact of Patient Navigation from Diagnosis to Treatment in ... An increasingly popular approach to improving cancer care outcomes has been navigator programs. The first patient navigator program was introduced by Dr Harold ...