Community Health Worker Program for Colorectal Cancer and Cardiovascular Disease

(CHURCH Trial)

Recruiting at 1 trial location

Overseen By Lisa Matthews, EdD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Non-English speaking, <45 years old

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

880 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new community-based program to prevent colorectal cancer (CRC) and reduce heart disease risks. It includes two main components: SBIRT (Screening, Brief Intervention, and Referral to Treatment) for early CRC screening and treatment, and a lifestyle program called "Alive!" that promotes healthier living to lower heart disease risks linked to CRC. Participants will either receive usual referral information or participate in the SBIRT program and the "Alive!" lifestyle guide. Ideal candidates are English-speaking individuals aged 45 and older who haven't had a recent CRC screening.

As an unphased trial, this study provides a unique opportunity to contribute to innovative prevention strategies for CRC and heart disease.

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 prior data suggests that this program is safe for participants?

Research has shown that the SBIRT approach used in this trial is generally safe. SBIRT stands for Screening, Brief Intervention, and Referral to Treatment. Initially developed for individuals at risk of mental health issues, this method has been tested and is considered safe and effective for promoting behavior change. It employs motivational interviewing to encourage positive changes, which participants have found manageable.

The Alive! program, included in this trial, is an online lifestyle coaching tool designed to enhance physical activity and eating habits. This program poses low risk as it provides guidance and support for healthier living.

Both components of the trial aim to improve health through education and motivation. Studies reviewed have not identified any specific negative effects or safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SBIRT approach for addressing colorectal cancer and cardiovascular disease because it's a novel way of combining behavioral health strategies with lifestyle coaching. Unlike traditional approaches that might focus solely on medical treatments or surgery, SBIRT integrates Screening, Brief Intervention, and Referral to Treatment with Motivational Interviewing to boost lifestyle changes. Additionally, the culturally-adapted Alive! Program offers a personalized, web-based platform to coach individuals on physical activity, eating habits, and weight control, making the intervention more accessible and tailored to individual needs. This dual focus on behavior change and lifestyle improvements sets it apart from standard care options, potentially leading to more sustainable health outcomes.

What evidence suggests that this trial's treatments could be effective for colorectal cancer and cardiovascular disease?

Research has shown that SBIRT (Screening, Brief Intervention, and Referral to Treatment) increases the number of people screened for health issues like colorectal cancer. It employs motivational interviewing, a method that encourages health changes by addressing mixed feelings. Studies have found that SBIRT effectively connects people to necessary treatments. In this trial, participants in the SBIRT arm will also receive a culturally-adapted online program called Alive!, which helps improve lifestyle habits like diet and exercise. Initial evidence suggests that combining these methods can lower risk factors for both colorectal cancer and heart disease. Meanwhile, participants in the Referral as Usual (RAU) arm will receive standard educational materials and contact information for screening services. ^{1 2 3 6 7}

Who Is on the Research Team?

Olajide A. Williams, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I am younger than 45 years old.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Screening, Brief Intervention, and Referral to Treatment (SBIRT) Experimental Treatment 1 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 Control 1 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.

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+

Published Research Related to This Trial

A community health worker (CHW)-delivered cancer education program significantly improved knowledge about colorectal cancer screening among 637 participants in a medically underserved area of Appalachian Kentucky, with scores rising from 4.27 to 4.57 after the intervention (p < .001).

The program also led to an increase in participants asking their healthcare providers about colorectal cancer screening, from 27.6% at baseline to 34.1% at follow-up (p = .013), demonstrating the effectiveness of CHWs in promoting health awareness and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in providing outreach and education for colorectal cancer screening in Appalachian Kentucky. Feltner, FJ., Ely, GE., Whitler, ET., et al.[2022]

Engaging community health workers in cancer screening interventions significantly increased screening rates for breast (11.5 percentage points), cervical (12.8 percentage points), and colorectal cancers (10.5 percentage points) across 76 studies, regardless of participants' race, income, or insurance status.

These interventions are effective whether community health workers operate independently or as part of a team, highlighting their role in improving health equity and access to cancer screening in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers to Increase Cancer Screening: 3 Community Guide Systematic Reviews. Okasako-Schmucker, DL., Peng, Y., Cobb, J., et al.[2023]

Training lay health workers (LHWs) about colorectal cancer (CRC) and screening significantly increased knowledge among participants, with 73 out of 81 recruited individuals having not previously received screening.

The outreach led to a substantial increase in CRC screening rates, with 55.7% of participants completing a fecal occult blood test after the educational sessions, demonstrating the effectiveness of LHWs in promoting health education and screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of lay health worker outreach and colorectal cancer screening among Chinese Americans. Nguyen, TT., Love, MB., Liang, C., et al.[2022]

Colorectal cancer screening is crucial for early detection and removal of precancerous polyps, as these polyps can take years to develop into cancer, highlighting the importance of regular screenings.

Modifiable risk factors, such as physical activity, weight control, and healthy dietary choices, account for a significant portion of colorectal cancer cases and deaths, suggesting that lifestyle changes can effectively reduce cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Food Choices, Physical Activity, and Screening Reduce the Risk of Colorectal Cancer. Morrow, L., Greenwald, B.[2022]

A community health worker-led intervention significantly increased colorectal cancer screening adherence among Hispanic workers, from 40% pre-intervention to 66% post-intervention, highlighting the effectiveness of targeted educational programs.

Knowledge about colorectal cancer was linked to age and perceived personal risk, indicating that older individuals and those who feel at risk are more likely to engage in screening, while lower-income workers may require additional support to improve adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer knowledge and screening adherence among low-income Hispanic employees. Ou, JY., Warner, EL., Nam, GE., et al.[2023]

A comprehensive, bilingual community-wide intervention significantly increased colorectal cancer screening rates among uninsured Hispanic individuals, with an uptake of 80.5% in the intervention group compared to only 17.0% in the control group.

The study involved 784 participants aged 50-75, and the intervention's effectiveness was consistent across different educational methods, demonstrating that such programs can effectively address screening disparities in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Against colorectal cancer in our neighborhoods (ACCION): A comprehensive community-wide colorectal cancer screening intervention for the uninsured in a predominantly Hispanic community. Shokar, NK., Byrd, T., Salaiz, R., et al.[2022]

In a study analyzing data from 5 NHANES cycles involving over 14,000 U.S. adults, it was found that 81% of adults aged 20 to 69 had at least one modifiable risk factor for colorectal cancer, highlighting a significant opportunity for prevention through lifestyle changes.

The research emphasizes that combining screening with lifestyle modifications could lead to a greater reduction in colorectal cancer rates, particularly as over 15% of adults under 50 had three or more risk factors, indicating a need for increased awareness and preventive measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities for the primary prevention of colorectal cancer in the United States. Joshu, CE., Parmigiani, G., Colditz, GA., et al.[2021]

Colorectal cancer (CRC) and cardiovascular disease (CVD) share many risk factors, highlighting the need for integrated prevention strategies that involve both oncologists and cardiologists.

Current treatments for CRC can lead to heart-related side effects, increasing the risk of CVD in survivors, which emphasizes the importance of multidisciplinary care for better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary prevention and management strategies for colorectal cancer and cardiovascular disease. Whelton, SP., Berning, P., Blumenthal, RS., et al.[2021]

Patients with colorectal cancer have a significantly higher risk of cardiovascular mortality, particularly within the first year after diagnosis, with a Standardized Mortality Ratio (SMR) of 11.7, indicating they are over 11 times more likely to die from cardiovascular disease compared to the general population.

Independent risk factors for cardiovascular mortality in these patients include older age, male sex, being African-American, elevated levels of carcinoembryonic antigen (CEA), and not undergoing curative surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for cardiovascular mortality in patients with colorectal cancer: a population-based study. Gaitanidis, A., Spathakis, M., Tsalikidis, C., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in Colorectal Cancer Screening Practices According to Cardiovascular Disease Status and Race/Ethnicity. Castañeda-Avila, MA., Lapane, KL., Jesdale, BM., et al.[2022]

A pilot intervention involving bilingual community health workers successfully educated 535 out of 691 low-income Latinas about cancer screening, leading to significant improvements in their knowledge of screening guidelines.

The intervention resulted in 25% of participants receiving scheduled cancer screenings, demonstrating the effectiveness of community health workers in increasing cancer screening rates among populations that are often under-screened.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast, Cervical, and Colorectal Cancer Education and Navigation: Results of a Community Health Worker Intervention. Mojica, CM., Morales-Campos, DY., Carmona, CM., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The educational intervention significantly improved knowledge and attitudes towards colorectal cancer screening among Chinese participants, with notable increases in perceived behavior control and behavioral beliefs compared to the control group.

While the intervention increased intentions to stay up to date with cancer screening in both Chinese and Vietnamese groups, these increases were not statistically significant, indicating that the program had mixed effects on screening intentions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving colorectal cancer screening in Asian Americans: Results of a randomized intervention study. Carney, PA., Lee-Lin, F., Mongoue-Tchokote, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05174286

Community Health Workers United to Reduce Colorectal ... The study intervention has two components: Screening, Brief Intervention, and Referral to Treatment (SBIRT) to address CRC screening and a web-based lifestyle ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38659874/

Community Health workers United to Reduce Colorectal ... Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11046862/

Community Health workers United to Reduce Colorectal ... Screening, brief intervention, and referral to treatment. Multiple studies have found SBIRT to be effective in increasing referral rates for mental health- ...

4. withpower.com withpower.com/trial/phase-cardiovascular-diseases-5-2022-8db40

Community Health Worker Program for Colorectal Cancer ... It compares the effectiveness of CHW-led SBIRT (Screening, Brief Intervention, Referral to Treatment) versus usual referral methods on CRC screening uptake and ...

5. omicsdi.org omicsdi.org/dataset/ecrin-mdr-crc/2399640

Community Health Workers United to Reduce Colorectal ... ABSTRACT: The overall goal of this study is to develop a comprehensive, culturally tailored community-based colorectal cancer (CRC) prevention model with a ...

6. library.samhsa.gov library.samhsa.gov/sites/default/files/sma13-4741.pdf

Technical Assistance Publication Series (Tap 33) A primary aspect of screening, brief intervention, brief treatment, and referral to treatment (SBIRT) is the integration and coordination of screening and ...

7. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11870-8

Improving screening, brief intervention and referral to ... SBIRT is a metric that uses several different ways to calculate performance outcomes, and the completeness and quality of the SBIRT data ...