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RECRUITING
NCT05174286
NA

Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

The overall goal of this study is to develop a comprehensive, culturally tailored community-based colorectal cancer (CRC) prevention model with a dual emphasis on reducing CRC risk along with its CVD risk factors. The study intervention has two components: Screening, Brief Intervention, and Referral to Treatment (SBIRT) to address CRC screening and a web-based lifestyle program called "Alive!" to address CVD risk factors linked to CRC. The C.H.U.R.C.H. Trial (Community Health workers (CHW) United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk) has four specific aims: (1) to compare the effect of a CHW-Led SBIRT (Intervention) to Referral As Usual (RAU) (Usual Care) on guideline-concordant CRC screening uptake; (2) to evaluate the effect of a Culturally Adapted CHW-linked Alive! (CACA) program incorporated into the intervention arm on dietary inflammatory score (DIS); (3) to evaluate the effect of CACA on changes in Life Simple-7 (LS7) scores; and (4) to examine the multi-level contextual mechanisms and factors influencing CHW effectiveness, reach, and implementation of CRC screening uptake and CACA activities through a mixed-methods process evaluation. Given the broad reach and influence of churches, results from this study can be used to inform future scale up of this multi-pronged intervention.

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

880

Start Date

2023-03-19

Completion Date

2026-08-31

Last Updated

2025-09-16

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

SBIRT

SBIRT is an evidence-based approach originally designed for people at risk of developing mental disorders. SBIRT is composed of three components: Screening with a validated instrument, Brief Intervention, Referral to Treatment. Motivational Interviewing (MI) is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. It decreases ambivalence and increases motivation for treatment. The investigators will utilize the Culturally-adapted Alive! Program - a cost-effective, lifestyle coaching web-based automated platform that includes step-by-step individualized tailoring, feedback, and weekly guidance through interactive emails focused on increasing physical activity, improving eating habits, and weight control.

BEHAVIORAL

Referral as Usual (RAU)

Referral as Usual will involve distributing CRC health educational materials (e.g. NCI or CDC brochures that include new guidelines) and contact information for screening service providers in our target community.

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States