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

Colorectal Cancer Clinical Trial

— CHURCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174286
• Other study ID #: AAAT9307
• Secondary ID: 1P50MD017341
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Lisa Matthews, EdD, MPH
• Phone: 212-853-1150
• Email: lam2160[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Black churches, results from this study can be used to inform future scale up of this multi-pronged intervention.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: August 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. English-speaking

2. Self-identifying as Black

3. Aged 45 years and older

4. Not up-to-date with CRC

5. Working telephone

6. Can provide informed consent

Exclusion Criteria:

1. Non-English speaking

2. <45 years old

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Dietary Inflammatory Score (Dietary Screening Measure)	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.	Baseline and 6 months post-screening
Secondary	Change in Life's Simple 7 Score (CVD Risk Screening Measure)	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.	Baseline, 6 months post-screening and 1 year post-screening