Patient Navigation for Colorectal Cancer Screening

(SCREEN Trial)

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

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

Compensation: Varies

Number of Visits: 5

1800 Participants Needed

Trial Summary

What is the purpose of this trial?

Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities, but there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices. The investigators will conduct a stepped-wedge, randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics (3 clinics per step, 5 six-month steps). Implementation strategies will include assessing for readiness, audit and feedback, building a community coalition, engaging consumers, modifying referral tracking, and training and educating clinical stakeholders. The research team will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership (OMOP) Common Data Model, additional patient-reported data, and study tracking logs to measure reach, effectiveness, adoption, implementation, and will use qualitative measures and site observations to document contextual factors, including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or colorectal cancer screening completion.

Will I have to stop taking my current medications?

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 Colorectal Cancer Screening?

Patient navigation has been shown to increase colorectal cancer screening rates, especially in underserved populations, and is effective in improving screening prevalence in community health centers. It also helps improve adherence to screening colonoscopy in diverse urban populations. ^{1 2 3 4 5}

Is patient navigation safe for humans?

The research articles do not provide specific safety data for patient navigation, but they focus on its role in improving colorectal cancer screening rates and addressing health disparities. ^{1 3 4 6 7}

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

Patient Navigation is unique because it involves guiding patients through the healthcare system to ensure they complete colorectal cancer screenings, especially for underserved populations. Unlike traditional treatments that focus on medical procedures, this approach addresses barriers to screening by providing personalized support and coordination, which has been shown to increase screening rates and reduce health disparities. ^{2 6 8 9 10}

Eligibility Criteria

This trial is for individuals from racial and ethnic minorities who are due for colorectal cancer screening. It aims to understand how well a patient navigation program works in different primary care clinics.

Inclusion Criteria

Identify as Black or Hispanic/Latino

I am between 45 and 75 years old.

I am due for a colorectal cancer screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Patient navigation and patient and provider reminders are rolled out across 15 clinics in a stepped-wedge design

30 months

5 steps, each lasting 6 months

Follow-up

Participants are monitored for colorectal cancer screening completion and other outcomes

12 months

Treatment Details

Interventions

• Patient Navigation

Trial Overview The study tests the effectiveness of patient navigation, reminders, and other strategies to improve colorectal cancer screening rates across 15 clinics using a stepped-wedge randomized design over five six-month steps.

Participant Groups

Group I: Patient navigation Experimental Treatment 1 Intervention

Patient navigation will be rolled out at the clinic level (15 clinics). Referral orders will become available to participating clinics, with education and audit and feedback for providers. The study team will tailor patient navigation supports by clinic site for specifics on how the intervention is delivered.

Group II: Usual care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

National Committee for Quality Assurance

Collaborator

Trials

3

Recruited

131,000+

Findings from Research

The study characterized 8 patient navigation programs under the National Cancer Institute's ACCSIS initiative, highlighting their diverse socio-ecological contexts and implementation strategies for colorectal cancer screening and follow-up.

Most programs adapted existing evidence-based navigation methods, with some starting navigation at the initial screening stage and others at follow-up, indicating flexibility in addressing patient needs and enhancing participation in colorectal cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative. Coronado, GD., Ferrari, RM., Barnes, A., et al.[2023]

Patient navigation (PN) improved initial colorectal cancer screening rates in underserved populations, but did not significantly increase the completion of follow-up screening colonoscopy (FSC) within the recommended six-month timeframe, with 53% of navigated patients completing FSC compared to 45% of unnavigated patients.

Despite the lack of a significant difference in overall completion rates, navigated patients showed higher odds of completing FSC when adjusted for factors like insurance and education, suggesting that PN may still have potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timeliness of Surveillance Colonoscopy in Underserved Populations: Association with Patient Navigation for Initial Screening Colonoscopy. Percac-Lima, S., Ashburner, JM., Enogieru, I., et al.[2021]

The patient navigator program in New York City successfully increased adherence to screening colonoscopy among a diverse population, with an overall adherence rate of 84.2% among 37,077 adults aged 50 and older.

The program demonstrated feasibility for expansion across 10 hospital sites, effectively reducing ethnic disparities in screening rates, as adherence was similar among black (83.2%), Hispanic (84.9%), and white (87.5%) adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation and Impact on Adherence to Screening Colonoscopy in a Large Diverse Urban Population. Mendelsohn, RB., DeLeon, SF., Calo, D., et al.[2022]

Colorectal cancer screening is crucial for reducing mortality, yet only 58.6% of adults are up-to-date with screenings, highlighting a significant gap in preventive care.

Implementing patient navigation interventions can effectively increase adherence to colorectal cancer screening and help reduce health disparities, but requires careful design considering factors like community characteristics, navigator qualifications, and evaluation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key considerations in designing a patient navigation program for colorectal cancer screening. DeGroff, A., Coa, K., Morrissey, KG., et al.[2021]

The patient navigation program in France significantly increased colorectal cancer screening participation by 3.3%, with a notable effect among affluent individuals (+4.1%) compared to deprived individuals (+2.6%).

While the program was more effective for affluent participants, it highlighted increased social inequalities in screening adherence when applied broadly; thus, it is recommended to focus navigation efforts on deprived populations, even though this approach may incur higher costs per additional individual screened.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. De Mil, R., Guillaume, E., Guittet, L., et al.[2018]

References

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

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative. [2023]

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

Characteristics of Effective Colorectal Cancer Screening Navigation Programs in Federally Qualified Health Centers: A Systematic Review. [2018]

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

Timeliness of Surveillance Colonoscopy in Underserved Populations: Association with Patient Navigation for Initial Screening Colonoscopy. [2021]

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

The economic impact of a patient navigator program to increase screening colonoscopy. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation and Impact on Adherence to Screening Colonoscopy in a Large Diverse Urban Population. [2022]

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

Key considerations in designing a patient navigation program for colorectal cancer screening. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Patient Navigation for Colonoscopy Completion: Results of an RCT. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A multilevel intervention to promote colorectal cancer screening among community health center patients: results of a pilot study. [2022]

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

What makes for successful patient navigation implementation in cancer prevention and screening programs using an evaluation and sustainability framework. [2022]

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

Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. [2018]