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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBIRT
Referral as Usual (RAU)
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring Community Health Workers, Colorectal Cancer, Cardiovascular Disease, Screening, Prevention

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • None

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Screening, Brief Intervention, and Referral to Treatment (SBIRT)

Referral as Usual (RAU)

Arm Description

Participants randomized to this arm will receive: 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. 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.

Participants randomized to this arm will receive Referral as Usual (RAU), which 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 5, 2021
Last Updated
August 31, 2023
Sponsor
Columbia University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05174286
Brief Title
Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk
Acronym
CHURCH
Official Title
Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 Black 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Community Health Workers, Colorectal Cancer, Cardiovascular Disease, Screening, Prevention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive: 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. 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.
Arm Title
Referral as Usual (RAU)
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive Referral as Usual (RAU), which 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
Intervention Name(s)
SBIRT
Other Intervention Name(s)
Culturally-adapted ALIVE! Program (CAP)
Intervention Description
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
Intervention Name(s)
Referral as Usual (RAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRC Screening Uptake
Description
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.
Time Frame
6 months post-screening
Secondary Outcome Measure Information:
Title
Change in Dietary Inflammatory Score (Dietary Screening Measure)
Description
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.
Time Frame
Baseline and 6 months post-screening
Title
Change in Life's Simple 7 Score (CVD Risk Screening Measure)
Description
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.
Time Frame
Baseline, 6 months post-screening and 1 year post-screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English-speaking Self-identifying as Black Aged 45 years and older Not up-to-date with CRC Working telephone Can provide informed consent Exclusion Criteria: Non-English speaking <45 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Matthews, MPH, EdD
Phone
212-853-1150
Email
lam2160@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Olajide A. Williams, MD, MS
Phone
212-342-3668
Email
ow11@columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olajide A. Williams, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olajide A. Williams, MD, MS
Phone
212-342-3668
Email
ow11@columbia.edu
First Name & Middle Initial & Last Name & Degree
Lisa Matthews, MPH, EdD
Phone
212-853-1150
Email
lam2160@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Olajide A. Williams, MD MS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available six months after publication in a peer-reviewed journal article.
IPD Sharing 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.
Citations:
PubMed Identifier
27034811
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.
Results Reference
background
PubMed Identifier
20043214
Citation
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.
Results Reference
background
PubMed Identifier
23086556
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.
Results Reference
background
PubMed Identifier
23718957
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.
Results Reference
background
PubMed Identifier
31538568
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.
Results Reference
background
PubMed Identifier
21287311
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.
Results Reference
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Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk

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