This clinical trial studies whether a community health worker (CHW) led program and a culturally adapted program can increase colorectal cancer (CRC) screening rates among people that are at a higher risk of developing CRC. African American (AA) adults are more likely to develop and die from CRC than any other racial group in the United States. Screening colonoscopies are highly associated with lowering CRC incidence and death. Despite this, AAs are the least likely to be screened, or adhere to risk reducing programs for CRC. The Screening, Brief Intervention, and Referral to Treatment (SBIRT) program is led by CHWs and is offered to churches with AA congregations. SBIRT uses a screening tool and motivational interviewing to review CRC screening guidelines as well as the benefits of undergoing CRC screening. Participants in the SBIRT program also receive a referral for CRC screening. The Culturally-adapted Alive! Program (CAP) is a web-based nutritional education and lifestyle coaching program. It is culturally tailored to AAs and designed to help participants lower intake of inflammatory foods and increase healthy lifestyle habits using goal setting and health information review. CAP participants also receive one on one coaching calls with a CHW. SBIRT and CAP may be effective methods to help AAs learn about the importance of CRC screening and healthy lifestyle habits. This may increase CRC screening and lower their risk of CRC.
Additional locations may be listed on ClinicalTrials.gov for NCT05174286.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterStatus: Active
Contact: Olajide A. Williams
Phone: 212-342-0941
PRIMARY OBJECTIVES:
I. To compare the effect of SBIRT (intervention) to Referral As Usual (RAU) (usual care) on guideline-concordant CRC screening uptake.
II. To evaluate the effect of a Culturally-adapted Alive! Program (CAP) incorporated into the intervention arm on dietary inflammatory score (DIS).
III. To evaluate the effect of CAP on changes in Life Simple-7 (LS7) scores.
IV. To examine the multi-level contextual mechanisms and factors influencing CHW effectiveness, reach, and implementation of CRC screening uptake and CAP activities.
OUTLINE: Churches are randomized to 1 of 2 arms and participants are assigned to the arm to which their church was randomized.
ARM I: Participants attend CHW-led SBIRT sessions twice monthly for 3 months and receive a referral for CRC screening during the SBIRT sessions. Participants also receive nutritional education and lifestyle coaching through the CAP program over 12 weeks and receive CHW coaching calls over 15-30 minutes once a week (QW) for 4 weeks and then once every two weeks (Q2W) for 8 weeks. Additionally, participants undergo blood sample collection throughout the study.
ARM II: Participants receive a National Cancer Institute (NCI) or Centers for Disease Control (CDC) CRC brochure promoting new CRC screening guidelines on study. Additionally, participants undergo blood sample collection throughout the study.
After completion of study intervention, participants are followed up at 6 months and 1 year.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorOlajide A. Williams
