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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to assist individuals in completing colonoscopies for colorectal cancer screening. It employs patient navigation, where trained guides support participants through phone calls, texts, and emails. The researchers aim to determine if this approach can boost screening rates, particularly in rural areas. Suitable candidates have been referred for a colonoscopy in the past three months, possibly following an abnormal stool test. As an unphased study, this trial provides a unique opportunity to contribute to innovative strategies that could enhance cancer screening accessibility.

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 this patient navigation program is safe for increasing colonoscopy completion?

Research shows that patient navigation is generally safe. This service helps patients obtain necessary medical tests. Studies have found that it increases the number of people screened for colorectal cancer, aiding them in completing colonoscopy appointments.

No evidence suggests that patient navigation causes harm. It primarily involves phone calls, texts, and emails to support patients. Without drugs or medical procedures, it avoids side effects associated with medicines.

Overall, evidence indicates that patient navigation assists patients without causing harm. It is a supportive service that simplifies healthcare management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigation intervention for colorectal cancer screening because it offers a personalized approach to help patients complete their colonoscopy screenings. Unlike standard educational brochures, this method uses trained navigators who provide support in the patient's preferred language through phone calls, texts, and emails. This tailored communication aims to address barriers to screening, potentially leading to higher completion rates and earlier detection of colorectal cancer.

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

Research has shown that patient navigation programs can increase colorectal cancer screening rates. In this trial, participants in the Patient Navigation Intervention arm will receive language-concordant assistance from a trained navigator to help complete colonoscopy screenings. One study found that a program combining mailed information and patient support increased screening by 7.3% compared to regular care. Patient navigation helps individuals overcome obstacles such as scheduling appointments or understanding the screening process. This method has also proven effective for breast and cervical cancer screenings. Overall, patient navigation effectively boosts participation in cancer screening programs. ^{1 2 6 7 8}

Who Is on the Research Team?

Allison M Cole, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Standard of 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+

Published Research Related to This Trial

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 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 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. 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.

3. 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10358261/

Components and effectiveness of patient navigation ... Patient navigation programmes are effective at increasing participation to breast, cervical and colorectal cancer screening.

5. academic.oup.com academic.oup.com/jnci/article/115/6/680/7050938

Characteristics of patient navigation programs in the Cancer ... Patient navigation is an evidence-based intervention that has been shown to substantially improve rates of colorectal cancer (CRC) screening and ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10248850/

Characteristics of patient navigation programs in the Cancer ... Although patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to ...