Multi-Level Intervention for Colorectal Cancer Screening

(ACCSIS Trial)

No longer recruiting at 1 trial location

Overseen By Mark B Dignan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kentucky

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 boost colorectal cancer (CRC) screening in specific areas of Kentucky and Ohio. Researchers are testing a community-wide approach, called a multi-level intervention, involving clinics, healthcare providers, and local residents to determine if it increases CRC screening rates. The trial includes two groups: one receives the new program first, while the other starts later. Ideal candidates for this trial are individuals aged 50 to 74 living in the targeted counties of Appalachian Kentucky and Ohio. As an unphased trial, it offers participants the opportunity to contribute to innovative community health strategies that could enhance CRC screening rates.

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

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

What prior data suggests that this multi-level intervention is safe for increasing CRC screening?

Research shows that methods to increase colorectal cancer (CRC) screening are generally well-received. Studies on these methods have not identified any major safety issues. For example, one study reported over a 10% increase in screening rates without negative effects. Another study observed a 20.29% increase in CRC screening rates, also without safety concerns. These results suggest that the methods are safe for participants. Since these studies reported no adverse events, participants can usually join these programs without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this multi-level intervention for colorectal cancer (CRC) screening because it tackles the issue from several angles, potentially leading to higher screening rates. Unlike standard practices, which might focus solely on individual patient reminders or educational materials, this intervention integrates various strategies at multiple levels, such as enhancing provider recommendations, improving clinic workflows, and increasing patient engagement. By addressing barriers on multiple fronts, this approach could significantly boost early detection rates, improving patient outcomes and possibly saving lives.

What evidence suggests that this trial's multi-level intervention could be effective for increasing colorectal cancer screening?

Research has shown that using multiple strategies can greatly increase the number of people screened for colorectal cancer (CRC). One study found a 20.29% increase in CRC screenings with these strategies. Another study showed that screening rates rose from 27% to 40% when offering stool-based tests. Effective methods include mailing tests to individuals and assisting them in navigating the healthcare system. This trial will test a multi-level intervention that operates at various levels, such as clinics, healthcare providers, and the community, making it a promising way to improve screening rates. Participants in this trial may receive the intervention immediately or later in the project. ^{1 2 5 6 7}

Who Is on the Research Team?

Mark B Dignan, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for residents aged 50-74 in certain Appalachian counties of Kentucky and Ohio, regardless of their race, sex, or gender. It aims to help increase colorectal cancer screening rates in these communities.

Inclusion Criteria

My race, sex, or gender does not limit my participation.

Resident of the study area

I am between 50 and 74 years old.

Exclusion Criteria

My eligibility is not affected by my gender, race, or ethnicity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multi-level Intervention

Implementation of a multi-level intervention targeting clinics, providers, patients, and the community to increase CRC screening rates

12 months

Follow-up

Participants are monitored for changes in CRC screening rates and follow-up care

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multi-level intervention to increase CRC screening

Trial Overview The study tests a multi-level intervention designed to boost colorectal cancer screenings by involving clinics, providers, patients, and the community. Half the counties start early while the other half begin later to compare effectiveness.

How Is the Trial Designed?

Group I: Multi-level Intervention Experimental Treatment 1 Intervention

Receives the project intervention first

Group II: Delayed Multi-level Intervention Active Control 1 Intervention

Offered the intervention later in the project

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S155171442500309X

A randomized clinical trial of multi-level intervention to ... The primary outcome is CRC screening completion (FIT or colonoscopy) within six months. Secondary outcomes include colonoscopy follow-up after a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8288035/

What Multi-Level Interventions Do We Need to Increase the ... The most effective interventions to increase screening include outreach with mailed or in-person distributed fecal blood tests; and patient navigation.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827032

Intervention and Outreach for Colorectal Cancer Screening The authors reported an absolute increase of 20.29 percentage points in CRC screening with the multilevel interventions, and a 24.3 percentage– ...

4. cdc.gov cdc.gov/pcd/issues/2025/25_0025.htm

Interventions to Increase Colorectal Cancer Screening ... We performed a scoping review to describe the types and effectiveness of interventions to increase CRC screening in primarily rural settings.

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11928-7

Multi-faceted strategies to advance health equity in colorectal ... The outcome measure was to increase the CRC screening rate from 27.0 to 40.0% in patients aged 50–75 by offering mt-sDNA stool-based testing and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7599111/

Implementing a multilevel intervention to accelerate colorectal ... The overall objective of this study is to provide the evidence base for multilevel interventions that increase rates of CRC screening, follow-up ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002222

Protocol for a Multilevel Intervention to Improve Screening ... The primary outcome is the completion rate of CRC screening at 90 days. Secondary outcomes include the screening completion rate at 180 days and the rate of ...