Patient Navigation for Colorectal Cancer Screening

(SCREEN Trial)

Enrolling by invitation at 18 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve colorectal cancer screening rates through a strategy called patient navigation. The focus is on effectively implementing this approach in primary care, particularly for Black and Hispanic/Latino individuals due for screening. Participants will receive guidance and reminders to assist with screening. Those who identify as Black or Hispanic/Latino, are between the ages of 45 and 75, and have a primary care visit at one of the selected clinics might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance healthcare strategies for diverse communities.

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 prior data suggests that patient navigation is safe for colorectal cancer screening?

Research has shown that patient navigation is a safe and well-accepted approach. Many studies have found that these services help people get screened for colorectal cancer without harmful side effects. Patient navigation guides individuals through the healthcare system, ensuring they receive the right screenings at the right time.

Patient navigation has been tested in various healthcare settings across the U.S. and has effectively increased the number of people getting screened. Importantly, no major negative effects have been linked to these services. This indicates that patient navigation is a safe way to help more people get screened for colorectal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about patient navigation for colorectal cancer screening because it offers a personalized approach to overcoming barriers that might prevent people from getting screened. Unlike standard methods that rely on patients to navigate the healthcare system on their own, patient navigation provides tailored support and guidance. This could include helping patients understand their screening options, scheduling appointments, and addressing any logistical or emotional concerns they may have. By directly addressing these obstacles, patient navigation has the potential to significantly increase screening rates and early detection, which is crucial for effective treatment of colorectal cancer.

What evidence suggests that patient navigation is effective for increasing colorectal cancer screening rates?

Research has shown that patient navigation, which participants in this trial may receive, effectively increases colorectal cancer screening rates. One study found that patient navigation led to a 7.3% increase in screenings compared to regular care. This method helps patients overcome obstacles to accessing healthcare services. Previous research also showed that patient navigation significantly improved adherence to screenings, although results varied by location. By guiding patients through the healthcare system, this approach helps fill gaps in cancer screening, especially in communities with less access to healthcare. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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. mdpi.com mdpi.com/2072-6694/17/21/3590

Qualitative Outcomes of Colorectal Cancer Screening ... We previously reported in Coronado et al. [35] that the patient navigation component of SMARTER CRC was effective at 6 months; among the 34 enrollees, follow-up ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12581864/

Application of Patient Navigation in Colorectal Cancer ... Efficacy evaluation demonstrated that patient navigation overall enhances colorectal cancer screening adherence, although heterogeneity existed ...

4. thecommunityguide.org thecommunityguide.org/findings/cancer-screening-patient-navigation-services-to-increase-colorectal-cancer-screening.html

Colorectal Cancer Screening: Patient Navigation Patient navigation services provided through healthcare systems help patients overcome barriers to accessing colorectal cancer screening.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831644

Mailed Outreach and Patient Navigation for Colorectal ... A mailed FIT outreach and patient navigation program led to a significant 7.3–percentage point increase in colorectal cancer (CRC) screening over usual care.

6. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.70121?af=R

Multilevel challenges and adaptations to patient navigation ... Patient navigation can substantially improve rates of colorectal cancer (CRC) screening and follow-up in multiple US health care settings.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01141114

Study of Patient Navigation to Promote Colon Cancer ... The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.

8. nccrt.org nccrt.org/wp-content/uploads/2023/12/2023-NCCRT-PPT-Master-Nov-16-C-Concurrent-Session-v2.pdf

Colorectal Cancer Screening Navigation in Action Project Aim: To increase screening rates for colorectal cancer. Project Activities: Mail-FIT campaign. Text Reminders. Patient Navigation. Colonoscopy MOUs.