Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk
CHURCH
2 other identifiers
interventional
880
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Mar 2023
Typical duration for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2021
CompletedFirst Posted
Study publicly available on registry
December 30, 2021
CompletedStudy Start
First participant enrolled
March 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
September 16, 2025
June 1, 2025
3.3 years
November 5, 2021
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CRC Screening Uptake
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.
6 months post-screening
Secondary Outcomes (2)
Change in Dietary Inflammatory Score (Dietary Screening Measure)
Baseline and 6 months post-screening
Change in Life's Simple 7 Score (CVD Risk Screening Measure)
Baseline, 6 months post-screening and 1 year post-screening
Study Arms (2)
Screening, Brief Intervention, and Referral to Treatment (SBIRT)
EXPERIMENTALParticipants 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.
Referral as Usual (RAU)
ACTIVE COMPARATORParticipants 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 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 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.
Eligibility Criteria
You may qualify if:
- English-speaking
- Aged 45 years and older
- Not up-to-date with CRC
- Working telephone
- Can provide informed consent
You may not qualify if:
- Non-English speaking
- \<45 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
Related Publications (8)
Jackson CS, Oman M, Patel AM, Vega KJ. Health disparities in colorectal cancer among racial and ethnic minorities in the United States. J Gastrointest Oncol. 2016 Apr;7(Suppl 1):S32-43. doi: 10.3978/j.issn.2078-6891.2015.039.
PMID: 27034811BACKGROUNDDe Jesus M, Puleo E, Shelton RC, McNeill LH, Emmons KM. Factors associated with colorectal cancer screening among a low-income, multiethnic, highly insured population: does provider's understanding of the patient's social context matter? J Urban Health. 2010 Mar;87(2):236-243. doi: 10.1007/s11524-009-9420-1. Epub 2009 Dec 31.
PMID: 20043214BACKGROUNDSly JR, Edwards T, Shelton RC, Jandorf L. Identifying barriers to colonoscopy screening for nonadherent African American participants in a patient navigation intervention. Health Educ Behav. 2013 Aug;40(4):449-57. doi: 10.1177/1090198112459514. Epub 2012 Oct 19.
PMID: 23086556BACKGROUNDLumpkins CY, Coffey CR, Daley CM, Greiner KA. Employing the church as a marketer of cancer prevention: a look at a health promotion project aimed to reduce colorectal cancer among African Americans in the Midwest. Fam Community Health. 2013 Jul-Sep;36(3):215-23. doi: 10.1097/FCH.0b013e31829159ed.
PMID: 23718957BACKGROUNDMaxwell AE, Lucas-Wright A, Santifer RE, Vargas C, Gatson J, Chang LC. Promoting Cancer Screening in Partnership With Health Ministries in 9 African American Churches in South Los Angeles: An Implementation Pilot Study. Prev Chronic Dis. 2019 Sep 19;16:E128. doi: 10.5888/pcd16.190135.
PMID: 31538568BACKGROUNDShelton RC, Thompson HS, Jandorf L, Varela A, Oliveri B, Villagra C, Valdimarsdottir HB, Redd WH. Training experiences of lay and professional patient navigators for colorectal cancer screening. J Cancer Educ. 2011 Jun;26(2):277-84. doi: 10.1007/s13187-010-0185-8.
PMID: 21287311BACKGROUNDWilliams O, Ting T, Matthews L, Block G, Block T, Teresi J, Eimicke J, Kong J, Silver S, Ravenell J, Mallaiah J, Jammalamadaka S, Nelson LM, Karmally W, Hankerson S. Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial. Trials. 2024 Apr 26;25(1):283. doi: 10.1186/s13063-024-08110-z.
PMID: 38671470DERIVEDWilliams O, Ting T, Matthews L, Block G, Block T, Teresi J, Eimicke J, Kong J, Silver S, Ravenell J, Mallaiah J, Jammalamadaka S, Nelson LM, Karmally W, Hankerson S. Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial. Res Sq [Preprint]. 2024 Apr 9:rs.3.rs-3797889. doi: 10.21203/rs.3.rs-3797889/v1.
PMID: 38659874DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olajide A. Williams, MD, MS
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
November 5, 2021
First Posted
December 30, 2021
Study Start
March 19, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
September 16, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available six months after publication in a peer-reviewed journal article.
- Access Criteria
- The study Investigators, Dr. Olajide Williams, will create criteria and review requests for data sharing access. Data will be available to analyze types of clinical and demographic factors impact study outcomes.
De-identified data will be shared through submission of study findings to peer-reviewed journals. De-identified data will also be shared at community forums and academic conferences.