Multilevel Intervention for Colorectal Cancer

Overseen By Rachel B. Issaka, MD, MAS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Colonoscopy, Age, 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 aims to determine if a special program, known as a Multilevel Intervention, can increase the number of people who undergo follow-up colonoscopies after an abnormal stool test result for colorectal cancer (CRC). The program provides additional support, including a patient navigator for scheduling assistance, an educational video to alleviate fears, and rideshare transportation home after the test. The goal is to assess whether these supports facilitate the completion of follow-up care. Ideal participants have already received an abnormal stool test result, have not yet undergone a colonoscopy, and receive care at specific clinics in Washington. As an unphased trial, this study focuses on improving patient experiences and outcomes, offering participants the opportunity to contribute to valuable research that could enhance future care.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this multilevel intervention is safe for increasing follow-up of abnormal colorectal cancer screening test results?

Research shows that the program under testing is generally safe for people. This program includes a patient navigator for support, an educational video to reduce fears about colonoscopies, and a rideshare service to assist patients in getting home after the procedure.

Early results suggest that these components are well-received, with no reports of serious side effects. The rideshare service, a non-medical option, has effectively ensured patients return home safely after their colonoscopy. Overall, the program is designed to provide support and ease the process, with no direct risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an innovative approach to improve colorectal cancer screening uptake and follow-through. Unlike the standard of care, which typically involves only regular contact and assistance with scheduling, this new protocol adds a personal touch by addressing patient fears through an educational video and offers logistical support via rideshare transportation home. By tackling both emotional and practical barriers to screening, the trial aims to increase participation and completion rates, potentially leading to earlier detection and better outcomes for patients.

What evidence suggests that this multilevel intervention is effective for increasing follow-up colonoscopy completion in patients with abnormal FIT results?

This trial will compare strategies to improve follow-up rates for abnormal colorectal cancer (CRC) screening results. Group I participants will receive usual care, including monthly phone calls and assistance with colonoscopy scheduling. Group II participants will receive the same usual care, plus additional support such as a video to address fears of colonoscopy and rideshare transportation after the procedure. Research has shown that using multiple strategies, like those in Group II, can improve follow-up rates by addressing different aspects of care, such as providing patient support and removing system barriers. One study found that these strategies, which include patient guides, educational videos, and transportation assistance, increased follow-up rates. Another study highlighted that patient guidance programs effectively help with challenges in CRC screening follow-up. Overall, using multiple strategies appears promising in ensuring patients complete important follow-up colonoscopies. ^{1 4 6 7 8}

Who Is on the Research Team?

Rachel B. Issaka, MD, MAS

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for patients with abnormal non-invasive colorectal cancer screening results who haven't followed up with a colonoscopy. It's designed to help those in under-resourced areas or with limited access to colonoscopies, by addressing patient and health system barriers.

Inclusion Criteria

Patients receiving care at Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) primary care clinic

Patients at least 1 month from documented abnormal FIT result

Patients who have not received a colonoscopy between the abnormal FIT and enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a multilevel intervention including a CRC screening program navigator, educational video, and transportation assistance to increase follow-up colonoscopy completion.

6 months

Monthly phone calls

Follow-up

Participants are monitored for colonoscopy completion and other outcomes after the intervention.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Multilevel Intervention

Trial Overview The PROACT Trial tests a multilevel intervention including support from a CRC screening navigator, an educational video about colonoscopies, and rideshare transportation post-procedure. The goal is to see if these combined efforts increase the rate of follow-up colonoscopies.

How Is the Trial Designed?

Group I: Group II (usual care, video, rideshare transportation) Experimental Treatment 6 Interventions

Patients receive usual care as described in Group I and additionally receive a QR code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study.

Group II: Group I (usual care) Active Control 2 Interventions

Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Timely colorectal cancer (CRC) screening is proven to significantly reduce CRC morbidity and mortality, yet only about two-thirds of the US population is up to date with recommended screenings, with even lower rates among vulnerable groups.

To effectively address these disparities, there is a need for a stronger evidence base that identifies the multilevel factors affecting screening and develops targeted interventions, utilizing systems science to optimize implementation strategies across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Powered Participatory Decision Making: Leveraging Systems Thinking and Simulation to Guide Selection and Implementation of Evidence-Based Colorectal Cancer Screening Interventions. Wheeler, SB., Leeman, J., Hassmiller Lich, K., et al.[2021]

This study aims to implement a comprehensive multilevel intervention to increase colorectal cancer (CRC) screening and follow-up care in federally qualified health centers, targeting organizational, provider, and individual levels to address disparities in CRC outcomes among vulnerable populations.

The intervention includes various components such as education for providers and staff, reminders, assessments, and patient navigation, and will be evaluated through a three-phase randomized trial involving four clinic clusters over a total of 15 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a multilevel intervention to accelerate colorectal cancer screening and follow-up in federally qualified health centers using a stepped wedge design: a study protocol. Kim, K., Polite, B., Hedeker, D., et al.[2021]

Multilevel interventions, which target various levels from individual to community, are believed to be more effective for cancer prevention and treatment than single-level interventions, but evidence supporting their superiority is still limited.

Research designs that assess the impact of these multilevel interventions on patient outcomes are rare, highlighting the need for studies that clarify how different levels of intervention contribute to health improvements in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel interventions: study design and analysis issues. Cleary, PD., Gross, CP., Zaslavsky, AM., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06822530

A Multilevel Intervention to Increase Colorectal Cancer ... This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11272441/

Multi-level interventions to improve colorectal cancer ... The primary outcome was completion of CRC screening within 6 months after the intervention. After the intervention phase, trained study ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425000047

Multilevel intervention for follow-up of abnormal FIT in the ... This study will assess the extent to which a multi-level intervention can improve timely colonoscopy completion in a diverse patient population cared for in a ...

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

Findings from the Accelerating Colorectal Cancer Screening ... This article highlights key challenges and adaptations in implementing patient navigation programs for colorectal cancer screening across ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8136225/

Development of a multilevel intervention to increase colorectal ... The main outcomes from ACCSIS are CRC screening, follow-up of abnormal tests, and referral to care; data to assess outcomes will come from the ...

6. withpower.com withpower.com/trial/phase-colorectal-neoplasms-3-2025-a215f

Multilevel Intervention for Colorectal Cancer This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, ...

7. frontiersin.org frontiersin.org/journals/health-services/articles/10.3389/frhs.2021.799816/full

Operationalizing a Rideshare Intervention for Colonoscopy ... The study aims to identify the barriers, facilitators, and process recommendations to implement a rideshare non-emergency medical transportation (NEMT) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8817893/

Operationalizing a Rideshare Intervention for Colonoscopy ... The study aims to identify the barriers, facilitators, and process recommendations to implement a rideshare non-emergency medical transportation (NEMT) ...