CRC Screening in Unscreened Individuals 45-54

NCT06757192 | Recruiting

• 1 other identifier: 24-219
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to understand the barriers and facilitators to completing colorectal cancer screening from the patient and community health center staff perspective. The main question it aims to answer is to identify system-level determinants of colorectal cancer screening in individuals aged 45 to 54. Participants will be asked to partake in one-time interviews either online or in-person and community health center staff will also be asked to take an online survey.

Conditions

Colorectal Cancer Screening

Keywords

colorectal cancer screening

Outcome Measures

Primary Outcomes (1)

• Measurement of acceptability and feasibility of implementation strategies

  For our primary outcome, participants will be asked to rate the acceptability and feasibility of implementation strategies using a previously validated instrument, which the investigator previously used with CHC staff. This tool has demonstrated good internal consistency reliability (0.85 for acceptability and 0.89 for feasibility) and similarly good test-retest reliability (correlations: acceptability- 0.80; feasibility - 0.88) and validity in a known groups analysis. There are no cut off numbers for acceptability and feasibility as these are just means but higher scores reflect higher acceptability. However, our surveys will allow us to better understand our survey findings. Quantitative survey interviews will be collected after first and second cycle of testing. The surveys and interviews will be measured together as this is a mixed methods study.

  From planning to testing and evaluation and assessment of outcomes will be a total of 12 months

Secondary Outcomes (1)

• Measurement of reach, effectiveness, and maintenance of implementation strategies

  From planning to testing and evaluation and assessment of outcomes will be a total of 12 months

Study Arms (1)

Patients and staff from one community health center named Codman Square Health Center.

This project builds on an existing partnership with Codman Square Health Center (CSHC). CSCHC is located in the Dorchester neighborhood of Boston which has among the highest mortality rates from colorectal cancer in the city. Codman Square Health Center serves a patient population that is 86% Black and 87% income at or below the federal poverty limit, thus requiring an equity-driven approach. Patients recruited will be aged 45-54 and staff will be over aged 18 who work at CSHC and that are involved in CRC screening. There will be no clinical intervention as this is an implementation study to identify system-level determinants of colorectal cancer screening.

Eligibility Criteria

• Age: 45 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Survey participants will involve staff members and providers (ages 18+) involved with CRC screening processes. Patients will be health center patients.

You may qualify if:

• Individuals aged 45-54
• Individuals who are patients at the health center
• Individuals that are willing and able to give verbal/written consent

You may not qualify if:

• Individuals with a personal history of CRC
• Individuals with a family history of CRC
• Individuals with a history of inflammatory bowel disease or high-risk cancer syndrome
• STAFF
• Individuals ages 18+
• Individuals working at the health center
• Individuals that are involved in CRC screening processes at CSHC
• Individuals that are willing and able to give verbal/written consent

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American College of Gastroenterology: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Codman Square Health Center

Boston, Massachusetts, 02124, United States

RECRUITING

Study Officials

• Adjoa Anyane-Yeboa, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adjoa Anyane-Yeboa, MD, MPH

CONTACT

(617) 726-6609; aanyane-yeboa@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 3, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

US (1)