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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

Must not have

Non-English speaking

Under 45 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months post-screening and 1 year post-screening

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I am younger than 45 years old.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months post-screening and 1 year post-screening for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CRC Screening Uptake

Secondary study objectives

Change in Dietary Inflammatory Score (Dietary Screening Measure)

Change in Life's Simple 7 Score (CVD Risk Screening Measure)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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: 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 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 Centers For Disease Control 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

0 / 3Eligibility criteria met