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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT05174286
• Lead Sponsor: Columbia University

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.

Detailed Description

Colorectal cancer (CRC) is the second most lethal cancer in the U.S with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these disparities, which includes premature mortality, AAs are the least likely to undergo CRC screening, have precancerous colorectal polys removed, and have CRC detected at stages early enough for curative excision. Lower screening rates are linked to the downstream effects of structural inequities such as access to care, knowledge of screening options and benefits, health system mistrust, fear and anxiety. Although reducing the burden of CRC is best accomplished by screening, compelling evidence links inflammatory diets and cardiovascular disease (CVD) risk factors to increased CRC risk. This proposal aims to develop a community-based prevention model to reduce CRC and cardiovascular disease (CVD) risk among AAs.

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-30
• Study Start: 2023-03-19
• Status Verified: 2025-06
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-16
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 880

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CRC Screening Uptake	6 months post-screening	Screening uptake (clinic-based colonoscopy or home-based stool test) (Primary Outcome) is the subject's self-report of completing a CRC screening test plus the research team's verification of this completion from medical records.

Secondary Outcome Measures

Name	Time	Method
Change in Dietary Inflammatory Score (Dietary Screening Measure)	Baseline and 6 months post-screening	Assessment of participant eating habits via the culturally-adapted ALIVE! program will be captured by the Block Food Frequency Questionnaire (FFQ) that generates the dietary inflammatory score (DIS) which can be used to examine associations between inflammatory diets, cardiovascular diseases and colorectal cancer.
Change in Life's Simple 7 Score (CVD Risk Screening Measure)	Baseline, 6 months post-screening and 1 year post-screening	Evaluation of CVD risk factors using the Life Simple-7 (LS7) measure. LS7 scores range from 0 to 14 and are calculated from the composite of the factor scores. CVD health is then classified as inadequate (0-4), average (5-9), or optimum (10-14). Achieving a greater number of ideal LS7 metrics is associated with lower risk of dying after stroke and all cause cardiovascular mortality in a dose dependent manner.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States