880 Participants Needed

Community Health Worker Program for Colorectal Cancer and Cardiovascular Disease

(CHURCH Trial)

Recruiting at 1 trial location
LM
OA
LM
Overseen ByLisa Matthews, EdD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on lifestyle changes and community health worker support.

What data supports the effectiveness of the treatment Referral as Usual (RAU), Referral as Usual, Usual Care, SBIRT, Screening, Brief Intervention, and Referral to Treatment for colorectal cancer and cardiovascular disease?

The research highlights the importance of community-based interventions and multidisciplinary approaches in improving screening and prevention for colorectal cancer and cardiovascular disease. These strategies can enhance early detection and management, potentially improving health outcomes for patients with these conditions.12345

Is the Community Health Worker Program for Colorectal Cancer and Cardiovascular Disease safe for humans?

The research articles provided do not contain specific safety data for the Community Health Worker Program or related interventions like Referral as Usual, Usual Care, or SBIRT. However, these types of programs generally focus on education and navigation support, which are typically safe for participants.678910

How does the SBIRT treatment differ from other treatments for colorectal cancer and cardiovascular disease?

SBIRT is unique because it involves community health workers providing education and support to increase awareness and adherence to screening for colorectal cancer, rather than focusing on direct medical interventions. This approach emphasizes outreach and education, particularly in underserved communities, to improve health outcomes.711121314

What is the purpose of this trial?

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.

Research Team

OA

Olajide A. Williams, MD, MS

Principal Investigator

Columbia University

Eligibility Criteria

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.

Inclusion Criteria

Can provide informed consent
I have a working telephone.
Not up-to-date with CRC
See 3 more

Exclusion Criteria

I am younger than 45 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the SBIRT intervention, including Screening, Brief Intervention, and Referral to Treatment, along with the culturally-adapted Alive! program for lifestyle coaching.

6 months
Regular virtual interactions through the Alive! program

Follow-up

Participants are monitored for CRC screening uptake and changes in dietary and cardiovascular health scores.

6 months
Follow-up assessments at 6 months and 1 year post-screening

Treatment Details

Interventions

  • Referral as Usual (RAU)
  • SBIRT
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Findings from Research

Community salons can play a crucial role in promoting cardiovascular disease (CVD) prevention and breast cancer screening, especially among women from diverse and socioeconomically deprived backgrounds in the UK.
A study involving 25 participants identified key factors for effective health promotion in salons, such as the importance of engaging in health conversations and facilitating access to healthcare, which can significantly improve screening uptake and early detection of diseases.
Factors affecting the delivery of community-based salon interventions to prevent cardiovascular disease and breast cancer among ethnically diverse women in South London: a concept-mapping approach.Zaman, M., de Vale, ML., Coultas, C., et al.[2023]
About 25% of US adults aged 50-75 have never been screened for colorectal cancer (CRC), with a notable disparity in screening rates among racial/ethnic groups, particularly higher rates of never being screened in Hispanics (35.3%) compared to non-Hispanic Whites (23.5%) and Blacks (20.6%).
Adults with cardiovascular disease (CVD) are more likely to be up-to-date with CRC screening, indicating that CVD may motivate better adherence to screening guidelines, as evidenced by lower odds of never being screened (adjusted odds ratio of 0.92) and being not up-to-date (adjusted odds ratio of 0.90) compared to those without CVD.
Variation in Colorectal Cancer Screening Practices According to Cardiovascular Disease Status and Race/Ethnicity.Castañeda-Avila, MA., Lapane, KL., Jesdale, BM., et al.[2022]
Colorectal cancer (CRC) patients with comorbid cardiovascular disease (CVD) reported significantly worse physical functioning and health-related quality of life (HRQoL) two years after diagnosis compared to those without CVD, highlighting the impact of cardiovascular health on cancer outcomes.
Patients with new-onset CVD experienced even greater declines in global quality of life, role functioning, and increased fatigue at one and two years post-diagnosis, suggesting that addressing cardiovascular issues in CRC patients is crucial for improving their overall well-being.
Colorectal cancer and cardiovascular disease: double the burden when it comes to your health-related quality of life?Bonhof, CS., Mols, F., Widdershoven, JW., et al.[2023]

References

Factors affecting the delivery of community-based salon interventions to prevent cardiovascular disease and breast cancer among ethnically diverse women in South London: a concept-mapping approach. [2023]
Variation in Colorectal Cancer Screening Practices According to Cardiovascular Disease Status and Race/Ethnicity. [2022]
Colorectal cancer and cardiovascular disease: double the burden when it comes to your health-related quality of life? [2023]
Multidisciplinary prevention and management strategies for colorectal cancer and cardiovascular disease. [2021]
Risk factors for cardiovascular mortality in patients with colorectal cancer: a population-based study. [2020]
Healthy Food Choices, Physical Activity, and Screening Reduce the Risk of Colorectal Cancer. [2022]
Colorectal cancer knowledge and screening adherence among low-income Hispanic employees. [2023]
Against colorectal cancer in our neighborhoods (ACCION): A comprehensive community-wide colorectal cancer screening intervention for the uninsured in a predominantly Hispanic community. [2022]
Opportunities for the primary prevention of colorectal cancer in the United States. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Breast, Cervical, and Colorectal Cancer Education and Navigation: Results of a Community Health Worker Intervention. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of community health workers in providing outreach and education for colorectal cancer screening in Appalachian Kentucky. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Improving colorectal cancer screening in Asian Americans: Results of a randomized intervention study. [2023]
Community Health Workers to Increase Cancer Screening: 3 Community Guide Systematic Reviews. [2023]
A pilot study of lay health worker outreach and colorectal cancer screening among Chinese Americans. [2022]
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