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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: t
View:

• English-speaking

• Aged 45 years and older

• Not up-to-date with CRC

• Working telephone

• Can provide informed consent

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Lisa Matthews, EdD, MPH
lam2160@cumc.columbia.edu
212-853-1150
Backup
Olajide A. Williams, MD, MS
ow11@columbia.edu
212-342-3668
Time Frame
Start Date: 2023-03-19
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 880
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

This content was sourced from clinicaltrials.gov