Enhanced Patient Navigation for Cancer Screenings

Overseen By Laura Tom, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Cognitive impairment, Incarceration, Under 21, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new approach, the "Patient Navigation 2.0 Checklist," can help individuals overcome barriers to cancer screenings, counseling, and vaccinations. Participants will either receive traditional one-on-one guidance (One-on-one Patient Navigation) to manage appointments and communication or use the new checklist, which focuses on personal challenges like access to care and social needs. It is designed for individuals who self-identify as Chinese, reside in specific Chicago areas, and can communicate in Cantonese, English, Mandarin, or Toishanese. As an unphased study, this trial offers a unique opportunity to contribute to innovative healthcare solutions and improve access to essential services.

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 these patient navigation methods are safe?

Research shows that patient navigation, whether conducted one-on-one or using the PN 2.0 Checklist, is generally safe and well-received.

Studies have found that patient navigation improves access to cancer care and increases screening rates. It helps individuals overcome obstacles to receiving necessary care. No reports of serious side effects have emerged from one-on-one patient navigation programs.

Past trials have shown that the PN 2.0 Checklist effectively improves the consistency of cancer care. It also addresses social issues impacting health, such as transportation or safe housing. Again, no reports of harmful side effects have been noted.

In summary, both types of patient navigation in this study are considered safe, with research supporting their benefits in improving healthcare access without adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Patient Navigation trial because it aims to tackle cancer screening barriers in innovative ways. The One-on-One Patient Navigation approach offers personalized support, helping patients schedule appointments, reminding them, and addressing obstacles through education and community resources. Meanwhile, the Patient Navigation 2.0 Checklist takes a systematic approach by identifying and addressing social determinants of health that might hinder screenings, while also ensuring patients complete recommended screenings, counseling, and immunizations. These methods stand out because they focus on both personal guidance and systematic barriers, potentially leading to better access and adherence to cancer screenings.

What evidence suggests that this trial's interventions could be effective for improving cancer screenings and addressing social determinants of health?

Research has shown that having a personal guide increases cancer screening rates for breast, cervical, and colorectal cancers. These guides assist by making appointments and connecting patients with resources, which is especially helpful for underserved groups. Some studies found that screening rates can increase by up to 15.6% with this support. In this trial, participants in Group 1 will receive One-on-One Patient Navigation, based on a Case Management Model.

Participants in Group 2 will use the Patient Navigation 2.0 Checklist, which effectively addresses social factors like income and education that impact health. This checklist helps ensure patients complete necessary cancer screenings and follow-up care. This approach has significantly improved the consistency of cancer care. ^{1 2 3 6 7}

Who Is on the Research Team?

Melissa Simon, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 21 living in specific Chicago areas (zip codes: 60605, 60607, 60608, 60609, 60616, 60623, 60632, or 60653), who identify as Chinese and can communicate in Cantonese, English, Mandarin or Toishanese. It's not for those unable to consent due to cognitive impairment or incarceration.

Inclusion Criteria

I am not experiencing any significant memory or thinking problems.

I am 21 years old or older.

Reside in one of the eight Chicago zip codes corresponding to Chinatown's geographical boundaries: 60605, 60607, 60608, 60609, 60616, 60623, 60632, 60653

Exclusion Criteria

I am an adult who cannot give consent.

I have difficulty with memory or thinking clearly.

Incarceration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are navigated using either the 'PN 2.0 Checklist' or 'One-on-One PN' to address social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations

18 months

Initial survey and every 6 months

Follow-up

Participants are monitored for the receipt of clinical cancer preventive services and resolution of social determinants of health barriers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• One-on-one Patient Navigation (PN)
• Patient Navigation (PN) 2.0 Checklist

Trial Overview The study tests a 'Patient Navigation (PN) Checklist' designed to help cancer patients manage their health by focusing on social factors and ensuring they get the right screenings and immunizations.

How Is the Trial Designed?

Group I: Group 2: Patient Navigation 2.0 Checklist Experimental Treatment 1 Intervention

The PN 2.0 Checklist intervention is centered on a learning health system checklist that enumerates a patient's Social Determinants of Health (SDoH) related barriers and tracks completion of services to address SDoH (at community oncology and community social service settings) as well as completion of USPSTF recommended cancer-related screenings, behavioral counseling, and immunizations.

Group II: Group 1: One-on-One Patient Navigation Active Control 1 Intervention

One-on-one Patient Navigation will be based on a Case Management Model where patients navigators perform appointment scheduling and reminders; facilitate communication between patients and care teams; and identify and reduce patient barriers through education, outreach, and referrals to community, local, and state resources.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Northeastern Illinois University

Collaborator

Trials

3

Recruited

850+

Northeastern Illinois University

Collaborator

Trials

2

Recruited

790+

Chinese American Service League

Collaborator

Trials

1

Recruited

600+

Rutgers, The State University of New Jersey

Collaborator

Trials

471

Recruited

81,700+

Mercy Hospital and Medical Center, Illinois

Collaborator

Trials

2

Recruited

660+

Published Research Related to This Trial

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

A randomized clinical trial involving 1612 patients showed that patient navigation (PN) significantly improved cancer screening rates for breast, cervical, and colorectal cancers, with completion rates of 10.2% in the PN group compared to 6.8% in the control group.

The PN intervention was particularly effective, leading to higher screening completion rates across all cancer types: breast (23.4% vs 16.6%), cervical (14.4% vs 8.6%), and colorectal (13.7% vs 7.0%), indicating that integrating PN into healthcare can enhance cancer screening in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. Percac-Lima, S., Ashburner, JM., Zai, AH., et al.[2022]

In a study involving 862 patients across 18 clinics, patient navigation (PN) significantly reduced the time to diagnostic resolution for individuals with abnormal cancer screening tests, showing a 65% higher resolution rate at 15 months compared to those without PN.

The benefits of PN became evident starting at six months after the detection of abnormalities, suggesting that this intervention could effectively address health disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ohio Patient Navigation Research Program: does the American Cancer Society patient navigation model improve time to resolution in patients with abnormal screening tests? Paskett, ED., Katz, ML., Post, DM., et al.[2021]

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 (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]

A standardized national training program for patient navigators (PNs) was successfully implemented, attended by 116 PNs from 85 cities, aimed at reducing cancer health disparities for medically underserved populations.

The training showed significant efficacy, with overall improvements in posttest scores compared to pretest scores, particularly among participants with higher education levels or more work experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national patient navigator training program. Calhoun, EA., Whitley, EM., Esparza, A., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7573022/

Effectiveness of Patient Navigation to Increase Cancer ... The goal of this study is to evaluate the effectiveness of patient navigation services in increasing colorectal, breast, and cervical cancer screening rates in ...

2. 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 ...

3. 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 ...

4. womenspreventivehealth.org womenspreventivehealth.org/wp-content/uploads/Patient-Navigation-Evidence-Review-Nov-25-2024.pdf

Patient Navigation Services for Breast and Cervical Cancer ... Outcomes included breast and cervical cancer screening rates within 1 year of the intervention, follow-up rates within 2 years, and any type of ...

5. jons-online.com jons-online.com/issues/2017/july-2017-vol-8-no-7/1648-patient-navigation-effectiveness

Patient Navigation Effectiveness on Improving Cancer ... The authors present the results of an analysis of the evidence for patient navigation effectiveness to improve cancer screening rates.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925005131

A randomized trial of patient navigation with symptom ... Patient navigators can help overcome barriers to cancer care. We evaluated the impact of patient navigation with symptom-monitoring in patients ...

7. prescancerpanel.cancer.gov prescancerpanel.cancer.gov/reports-meetings/enhancing-patient-navigation-2024/achieving-equity-cancer-care

Part I. Achieving Equity in Cancer Care: The Need for ... Patient navigation is an evidence-based intervention that was developed to address disparities in cancer care and outcomes.