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

NCT ID: NCT05174286

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-19
• Study Completion Date: 2026-08-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SBIRT

Intervention Type: BEHAVIORAL

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)

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.

Group Type: ACTIVE_COMPARATOR

Referral as Usual (RAU)

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Culturally-adapted ALIVE! Program (CAP)

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Olajide Williams

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olajide A. Williams, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa Matthews, EdD, MPH

Role: CONTACT

lam2160@cumc.columbia.edu

212-853-1150

Olajide A. Williams, MD, MS

Role: CONTACT

ow11@columbia.edu

212-342-3668

Facility Contacts

Olajide A. Williams, MD, MS

Role: primary

ow11@columbia.edu

212-342-3668

Lisa Matthews, MPH, EdD

Role: backup

lam2160@cumc.columbia.edu

212-853-1150

References

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.

Reference Type: BACKGROUND

PMID: 27034811 (View on PubMed)

De 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.

Reference Type: BACKGROUND

PMID: 20043214 (View on PubMed)

Sly 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.

Reference Type: BACKGROUND

PMID: 23086556 (View on PubMed)

Lumpkins 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.

Reference Type: BACKGROUND

PMID: 23718957 (View on PubMed)

Maxwell 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.

Reference Type: BACKGROUND

PMID: 31538568 (View on PubMed)

Shelton 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.

Reference Type: BACKGROUND

PMID: 21287311 (View on PubMed)

Williams 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.

Reference Type: DERIVED

PMID: 38671470 (View on PubMed)

Williams 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.

Reference Type: DERIVED

PMID: 38659874 (View on PubMed)

Other Identifiers

1P50MD017341

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT9307

Identifier Type: -

Identifier Source: org_study_id