Positive Fit to Colonoscopy: Closing the Gap

NCT06763432 | Recruiting

• 2 other identifiers: 2421982578
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this proposal are to: (1) identify patient- and system-level determinants of diagnostic colonoscopy after positive FIT; (2) identify patient- and system-level equity-driven implementation strategies for diagnostic colonoscopy after positive FIT matched to determinants; and (3) pilot test patient- and systems-level implementation strategies to increase rate of colonoscopy after positive FIT and determine feasibility and acceptability of strategies using mixed methods

Conditions

Colorectal Cancer Screening

Keywords

colorectal cancer screening

Outcome Measures

Primary Outcomes (2)

• Measurement of Acceptability and Feasibility of a validated survey

  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.

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

• Measurement of Acceptability and Feasibility of semi structure interviews

  The investigator will conduct semi structure interviews to further understand participants' perceptions around feasibility and acceptability.

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

Secondary Outcomes (6)

• Measurement of reach of descriptive statistics

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

• Measurement of reach of semi structure interviews

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

• Measurement of effectiveness using descriptive statistics

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

• Measurement of maintenance using descriptive statistics

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

• Measurement of maintenance of semi structure interviews

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

Study Arms (1)

Patients and staff will be recruited from 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 will be aged 45-75 and staff will be over 18 who currently work at CSHC in CRC screening. There is no intervention as this is an implementation study to identify patient- and system-level determinants of diagnostic colonoscopy after positive FIT test in individuals using mixed methods.

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Codman Square Health Center patients aged 45-75 who do not have a personal or family history of colorectal cancer, inflammatory bowel disease, or a high-risk cancer syndrome. Codman Square Health Center staff ages 18+ that are involved in colorectal cancer screening processes at Codman Square Health Center.

You may qualify if:

• Individuals aged 45-75
• Individuals who are patients at Codman Square Health Center
• Individuals that are willing and able to give verbal/written consent

You may not qualify if:

• Individuals with a personal history of colorectal cancer
• Individuals with a family history of colorectal cancer
• Individuals with a history of inflammatory bowel disease or high-risk cancer syndrome

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Codman Square Health Center

Boston, Massachusetts, 02124, United States

RECRUITING

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 8, 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)