Recruiting

Community Health Workers

Sponsor:

Columbia University

Code:

NCT05174286

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Interventions

SBIRT

Referral as Usual (RAU)

Study Details

Brief 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.

Conditions

Colorectal Cancer

Study ID

NCT05174286

Start date

Mar 19, 2023

Status verified date

Jun, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. English-speaking
2. Aged 45 years and older
3. Not up-to-date with CRC
4. Working telephone
5. Can provide informed consent

Exclusion Criteria:

1. Non-English speaking
2. <45 years old

Study Design

Enrollment

880 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Screening, Brief Intervention, and Referral to Treatment (SBIRT)

Participants randomized to this arm will receive:

1. 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.
2. Culturally-adapted Alive! Program, which is 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.

active comparator: Referral as Usual (RAU)

Participants randomized to this arm will receive Referral as Usual (RAU), which will involve distributing CRC health educational materials (e.g. NCI or Centers For Disease Control brochures that include new guidelines) and contact information for screening service providers in our target community.

Interventions

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.

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.

Primary outcome measure

  • CRC Screening Uptake [ Time Frame: 6 months post-screening ]

Central Contacts and Locations

Central contacts

Lisa Matthews, EdD, MPH

212-853-1150lam2160@cumc.columbia.edu

Olajide A. Williams, MD, MS

212-342-3668ow11@columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Olajide A. Williams, MD, MS

212-342-3668ow11@columbia.edu

Lisa Matthews, MPH, EdD

212-853-1150lam2160@cumc.columbia.edu

Principal Investigator:

Olajide A. Williams, MD MS

More Information

Sponsor

Columbia University

Last update posted

Sep 16, 2025

Last verified

Jun, 2025

Keywords

  • Community Health Workers
  • Colorectal Cancer
  • Cardiovascular Disease
  • Screening
  • Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-09-16.