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

682 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.

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.

Is the Multilevel Intervention for Colorectal Cancer safe for humans?

The research articles provided do not contain specific safety data for the Multilevel Intervention for Colorectal Cancer or its use in humans for other conditions. ^{1 2 3 4 5}

How does the Multilevel Intervention treatment for colorectal cancer differ from other treatments?

The Multilevel Intervention for colorectal cancer is unique because it targets multiple levels of influence, such as the organization, provider, and individual, to improve screening, follow-up, and care referral. This approach is more comprehensive than single-level interventions, aiming to address various factors that contribute to disparities in cancer care. ^{1 2 3 4 5}

Research Team

Rachel B. Issaka, MD, MAS

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Designing studies that would address the multilayered nature of health care. [2021]

2. England 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. [2021]

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

Multilevel interventions: study design and analysis issues. [2021]

4. United States 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. [2021]

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

Implementation and spread of interventions into the multilevel context of routine practice and policy: implications for the cancer care continuum. [2021]