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Community Health Worker Program for Colorectal Cancer and Cardiovascular Disease (CHURCH Trial)
N/A
Recruiting
Led By Olajide A. Williams, MD, MS
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 45 years and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months post-screening and 1 year post-screening
Awards & highlights
CHURCH Trial Summary
This trial is testing whether a community health worker-led program can increase colorectal cancer screening rates and reduce dietary and cardiovascular risk factors in African American communities.
Who is the study for?
This trial is for English-speaking Black individuals aged 45 and older who are not current with colorectal cancer (CRC) screenings, have a working telephone, and can provide informed consent. There are no specific exclusion criteria listed.Check my eligibility
What is being tested?
The study tests a community-based CRC prevention model focusing on reducing both CRC and cardiovascular disease risks. It compares the effectiveness of CHW-led SBIRT (Screening, Brief Intervention, Referral to Treatment) versus usual referral methods on CRC screening uptake and evaluates a web-based program 'Alive!' targeting CVD risk factors.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like health education and lifestyle programs rather than drugs or medical procedures, traditional side effects are not applicable. However, participants may experience changes in diet or stress due to lifestyle adjustments.
CHURCH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 45 years old or older.
CHURCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months post-screening and 1 year post-screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months post-screening and 1 year post-screening
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CRC Screening Uptake
Secondary outcome measures
Change in Dietary Inflammatory Score (Dietary Screening Measure)
Change in Life's Simple 7 Score (CVD Risk Screening Measure)
CHURCH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Screening, Brief Intervention, and Referral to Treatment (SBIRT)Experimental Treatment1 Intervention
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.
Group II: Referral as Usual (RAU)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBIRT
2012
Completed Phase 2
~4990
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,459,953 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
382 Previous Clinical Trials
1,215,281 Total Patients Enrolled
Olajide A. Williams, MD, MSPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a working telephone.I do not speak English.I am younger than 45 years old.I am 45 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Referral as Usual (RAU)
- Group 2: Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research currently enlisting participants?
"Clinicaltrials.gov shows that this particular trial, which was initially announced on June 15th 2022 and has since been updated in December 2021, is not seeking applicants currently. Nonetheless, there are still 1478 other clinical studies actively recruiting individuals at the moment."
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