Patient Navigation for Colorectal Cancer Screening

Overseen By Brooke Ike, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Colorectal cancer, Total colectomy, others

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

Compensation: Varies

Number of Visits: Unknown

527 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to test the effectiveness of a patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.

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, by helping patients complete their initial screenings and follow-up procedures. Studies indicate that patient navigation programs can improve adherence to screening schedules and may help reduce disparities in cancer screening and outcomes. ^{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, especially in underserved populations. ^{1 2 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 increase colorectal cancer screening rates, especially among underserved populations. Unlike traditional treatments, it focuses on personalized support and coordination to overcome barriers to screening, rather than directly treating the cancer itself. ^{3 6 8 9 10}

Research Team

Allison M Cole, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for rural residents aged 45-75 who've been referred for a colonoscopy as part of colorectal cancer screening within the last three months. It's not open to those who've already had a colonoscopy since referral, live long-term in institutions (if over 65), are on hospice care, or have had colorectal cancer or total colectomy.

Inclusion Criteria

I was referred for a colonoscopy for colorectal cancer screening recently.

I am between 45 and 76 years old.

Exclusion Criteria

I am 66 or older and have lived in a care facility for over 90 days last year.

I am currently receiving hospice care.

I have had a colonoscopy since being referred for one.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Patient Navigation Intervention

Participants receive language-concordant patient navigation from a trained navigator to assist in completing colonoscopy

8-12 weeks

Phone, text, and email communication

Usual Care Control

Participants receive an educational brochure about the importance of colonoscopy

8-12 weeks

Follow-up

Participants are monitored for colonoscopy completion and program effectiveness

4 weeks

Treatment Details

Interventions

• Patient Navigation
• Usual Care Control

Trial Overview The study is testing if a patient navigation program helps increase the rate at which people complete their recommended colonoscopies for colorectal cancer screening compared to usual care. Participants will be recruited from various primary care organizations.

Participant Groups

Group I: Usual Care Control Experimental Treatment 1 Intervention

Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.

Group II: Patient Navigation Intervention Experimental Treatment 1 Intervention

Patients randomized to this arm will receive language-concordant patient navigation from a trained navigator, over the phone and via text and email, to assist patients to complete colonoscopy to screen for colorectal cancer.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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 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]

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

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

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

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

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

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

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]