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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates whether a "Patient Navigation 2.0 Checklist" intervention is effective in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.

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 One-on-one Patient Navigation (PN), Patient Navigation (PN) 2.0 Checklist for cancer screenings?

Research shows that patient navigation (PN) programs can help improve cancer screening rates, especially for people who face language barriers or are from underserved communities. These programs have been effective in ensuring timely follow-up after abnormal screening results, which can lead to quicker diagnosis and treatment. ^{1 2 3 4 5}

Is patient navigation safe for humans?

The research articles reviewed do not report any safety concerns related to patient navigation programs, suggesting they are generally safe for humans. ^{2 3 4 6 7}

How is the Enhanced Patient Navigation treatment for cancer screenings different from other treatments?

The Enhanced Patient Navigation treatment is unique because it provides personalized, one-on-one support to help patients overcome barriers to cancer screenings, especially in underserved populations. This approach focuses on improving access and equity in healthcare by guiding patients through the screening process, which is not typically addressed by standard treatments. ^{2 3 4 8 9}

Research Team

Melissa Simon, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

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

Navigating Language Barriers: A Systematic Review of Patient Navigators' Impact on Cancer Screening for Limited English Proficient Patients. [2023]

2. United States 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? [2021]

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

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

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

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

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. [2018]

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

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

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

The efficacy and cost-effectiveness of patient navigation programs across the cancer continuum: A systematic review. [2020]

8. United States 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. [2022]

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

A national patient navigator training program. [2021]