Community Health Worker Program for Colorectal Cancer and Cardiovascular Disease
(CHURCH Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byOlajide A. Williams, MD, MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Non-English speaking, <45 years old
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
711121314Eligibility 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
+3 more
Exclusion Criteria
I do not speak English.
I am younger than 45 years old.
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Columbia University Medical CenterNew York, NY
Columbia University Irving Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
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]In the UK, women from ethnically diverse and socioeconomically deprived communities are at increased risk of underdiagnosis of cardiovascular disease (CVD) and breast cancer. Promoting CVD prevention and awareness of breast cancer screening via community salons and primary health care partnerships can improve uptake of screening services and early detection.
Variation in Colorectal Cancer Screening Practices According to Cardiovascular Disease Status and Race/Ethnicity. [2022]To assess current estimates of colorectal cancer (CRC) screening practices in relation to cardiovascular disease (CVD) status and whether this association varies by race/ethnicity.
Colorectal cancer and cardiovascular disease: double the burden when it comes to your health-related quality of life? [2023]The prevalence of comorbid cardiovascular disease (CVD) among patients with colorectal cancer (CRC) has increased in the last decades. Previous studies have focused on the impact of comorbid CVD on clinical outcomes in CRC, while its impact on patients' health-related quality of life (HRQoL) is understudied. This study, therefore, relates (new-onset) CVD to HRQoL (i.e., physical, role, cognitive, emotional, and social functioning, and two CVD-related symptom scales fatigue and dyspnea) in a two-year follow-up study among CRC patients.
Multidisciplinary prevention and management strategies for colorectal cancer and cardiovascular disease. [2021]Colorectal cancer (CRC) and cardiovascular disease (CVD) are leading causes of morbidity and mortality worldwide. Their numerous shared and modifiable risk factors underscore the importance of effective prevention strategies for these largely preventable diseases. Conventionally regarded as separate disease entities, clear pathophysiological links and overlapping risk factors represent an opportunity for synergistic collaborative efforts of oncologists and cardiologists. In addition, current CRC treatment approaches can exert cardiotoxicity and thus increase CVD risk. Given the complex interplay of both diseases and increasing numbers of CRC survivors who are at increased risk for CVD, multidisciplinary cardio-oncological approaches are warranted for optimal patient care from primary prevention to acute disease treatment and long-term surveillance.
Risk factors for cardiovascular mortality in patients with colorectal cancer: a population-based study. [2020]Patients with colorectal cancer are at increased risk of cardiovascular mortality compared to the general population. The purpose of this study is to identify risk factors of cardiovascular mortality in patients with colorectal cancer.
Healthy Food Choices, Physical Activity, and Screening Reduce the Risk of Colorectal Cancer. [2022]Cancer is the second leading cause of death in the United States with an estimated 1,806,590 new cases and 606,520 deaths in 2020. Cancer is a public health concern due to the numbers of cases, financial costs, and morbidity and mortality rates. An estimated 42% of all diagnosed cancers and 45% of cancer deaths in the United States in 2014 could be attributed to modifiable risk factors. Colorectal cancer screening is effective because small polyps take years to grow and turn to cancers allowing for early detection and removal of precancerous polyps. Primary prevention of colorectal cancer by risk factor reduction is also effective as these factors cause over half of colorectal cancer cases and deaths. Physical activity, weight control, healthy dietary choices, and abstinence from alcohol and tobacco are protective. The gastroenterology nurse can assess physical activity and food choices as vital signs and recommend a gradual addition of physical activity and a more plant-based diet with reduced processed food. All nurses need to advocate for policy improvements per our pledge to the Code of Ethics for Nurses. Policy changes improve the health of large numbers of people and make healthy behaviors a normalized way of life.
Colorectal cancer knowledge and screening adherence among low-income Hispanic employees. [2023]Hispanics have the lowest colorectal cancer (CRC) screening rates of all racial/ethnic groups and comprise the largest proportion of low-income manual laborers in the nation. We partnered with businesses to implement a community health worker (CHW)-led intervention among Hispanic workers in service-related and manual labor occupations, which often pay low wages and do not provide health insurance. CHWs measured knowledge, screening adherence and perceptions of CRC risk before and after educational interventions via interview. CHWs provided fecal immunochemical tests (FITs) to participants aged ≥50 years. Chi-square tests and logistic regression identified pre-intervention predictors of CRC knowledge of all participants and adherence among eligible participants. Adherence among participants increased from 40% (n = 307) pre-intervention to 66% post-intervention. Knowledge about CRC was associated with age ≥50 years (OR = 8.90 [95% CI = 2.61-30.35]; ref = 18-30) and perceived personal risk for CRC (Likely, OR = 3.06 [95% CI = 1.40-6.67]; ref = Not likely). Insurance status was associated with screening adherence pre-intervention (OR = 3.00 [95% CI 1.10-8.12]; ref = No insurance). Improvement in adherence post-intervention was associated with income between $25 000 and ≥$55 000 (OR = 8.49 [95% CI 1.49-48.32]; ref = $5000-
Against colorectal cancer in our neighborhoods (ACCION): A comprehensive community-wide colorectal cancer screening intervention for the uninsured in a predominantly Hispanic community. [2022]Colorectal cancer (CRC) is the second leading cause of cancer deaths in the USA. Screening is widely recommended but underutilized, particularly among the low income, the uninsured, recent immigrants and Hispanics. The study objective was to determine the effectiveness of a comprehensive community-wide, bilingual, CRC screening intervention among uninsured predominantly Hispanic individuals. This prospective study was embedded in a CRC screening program and utilized a quasi-experimental design. Recruitment occurred from Community and clinic sites. Inclusion criteria were aged 50-75years, uninsured, due for CRC screening, Texas address and exclusions were a history of CRC, or recent rectal bleeding. Eligible subjects were randomized to either promotora (P), video (V), or combined promotora and video (PV) education, and also received no-cost screening with fecal immunochemical testing or colonoscopy and navigation. The non-randomly allocated controls recruited from a similar county, received no intervention. The main outcome was 6month self-reported CRC screening. Per protocol and worst case scenario analyses, and logistic regression with covariate adjustment were performed. 784 subjects (467 in intervention group, 317 controls) were recruited; mean age was 56.8years; 78.4% were female, 98.7% were Hispanic and 90.0% were born in Mexico. In the worst case scenario analysis (n=784) screening uptake was 80.5% in the intervention group and 17.0% in the control group [relative risk 4.73, 95% CI: 3.69-6.05, P
Opportunities for the primary prevention of colorectal cancer in the United States. [2021]Several studies indicate that screening in combination with lifestyle modification may produce a greater reduction in colorectal cancer rates than screening alone. To identify national opportunities for the primary prevention of colorectal cancer, we assessed the prevalence of modifiable lifestyle risk factors in the United States. We used nationally representative, cross-sectional data from 5 NHANES cycles (1999-2000, n = 2,753; 2001-2002, n = 3,169; 2003-2004, n = 2,872; 2005-2006, n = 2,993; 2007-2008, n = 3,438). We evaluated the 5 colorectal cancer risk factors deemed "convincing" by the World Cancer Research Fund (obesity, physical inactivity, intake of red meat, processed meat, alcohol), and cigarette smoking, a "suggestive" risk factor in the Surgeon General's report. We estimated the prevalence of each risk factor separately and jointly, and report it overall, and by sex, race/ethnicity, age, and year. In 2007 to 2008, 81% percent of U.S. adults, aged 20 to 69 years, had at least one modifiable risk factor for colorectal cancer. More than 15% of those younger than 50 years had 3 or more risk factors. There was no change in the prevalence of risk factors between 1999 and 2008. The most common risk factors were risk factors for other chronic diseases. Our findings provide additional support for the prioritization of preventive services in health care reform. Increasing awareness, especially among young adults, that lifestyle factors influence colorectal cancer risk, and other chronic diseases, may encourage lifestyle changes and adherence to screening guidelines. Complementary approaches of screening and lifestyle modification will likely provide the greatest reduction of colorectal cancer.
Breast, Cervical, and Colorectal Cancer Education and Navigation: Results of a Community Health Worker Intervention. [2022]Now that cancer has surpassed heart disease as the top cause of death for Hispanics in the United States, it is even more critical to focus on early detection of cancer in this population. We report the results of a theory-driven education-plus-navigation pilot intervention delivered by bilingual, bicultural community health workers (CHWs) with the goal of increasing cancer screening rates and knowledge among low-income Latinas. CHWs enrolled 691 eligible women, ages 18 to 75 years, considered rarely or never screened for breast, cervical, and colorectal cancer. Eligible women were scheduled for an education session and offered health care navigation support with appointment scheduling and reminder/follow-up calls. CHWs provided education to 535 (77%) eligible women, and arranged mammograms, Pap tests, or stool blood tests for 174 (25%) participants, with another 94 (14%) placed on a waiting list at a local health center. Statistically significant positive changes on knowledge of screening guidelines for breast, cervical, and colorectal cancer, and beliefs/attitudes regarding early detection were observed from pre- to posttest among eligible women who attended an educational session. Results highlight the effectiveness of CHW-directed interventions in recruiting individuals for programs, educating them, and influencing cancer knowledge and screening behavior.
Effectiveness of community health workers in providing outreach and education for colorectal cancer screening in Appalachian Kentucky. [2022]The purpose of this study was to examine the effectiveness of a community health worker (CHW)-delivered cancer education program designed to increase knowledge and awareness of colorectal cancer screening options. The study population was an extremely vulnerable and medically underserved geographic region in Appalachian Kentucky. CHWs enrolled participants in face-to-face visits, obtained informed consent, and administered a baseline assessment of knowledge of colorectal cancer risks and the benefits of screening and screening history. An educational intervention was then provided and participants were re-contacted 6 months later when a posttest was administered. The mean score of the 637 participants increased from 4.27 at baseline to 4.57 at follow-up (p
Improving colorectal cancer screening in Asian Americans: Results of a randomized intervention study. [2023]The objective of this study was to use a randomized controlled trial design to test the impact of an educational intervention delivered by specially trained community health workers among Chinese, Korean, and Vietnamese participants ages 50 to 75 years on knowledge, attitudes, beliefs, and intentions regarding colorectal cancer screening.
Community Health Workers to Increase Cancer Screening: 3 Community Guide Systematic Reviews. [2023]Many in the U.S. are not up to date with cancer screening. This systematic review examined the effectiveness of interventions engaging community health workers to increase breast, cervical, and colorectal cancer screening.
A pilot study of lay health worker outreach and colorectal cancer screening among Chinese Americans. [2022]The research team recruited eight Chinese American (seven females, one male) lay health workers (LHWs). They received 12 h of training about colorectal cancer (CRC), its screening, and basic health education techniques. Each LHW were asked to recruit ten participants and conduct two educational sessions. Of the 81 participants recruited, 73 had not received colorectal cancer screening. Their mean age was 63.0 years, and 72.6% were women. Knowledge of colorectal cancer, its causes, and its screening increased significantly. Receipt of first colorectal cancer screening test increased from 0.0% at baseline to 55.7% for fecal occult blood tests, 7.1% for sigmoidoscopy, and 7.1% for colonoscopy. LHW outreach is feasible and may be effective in promoting CRC screening among Chinese Americans.