Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06763432

Conditions

Colorectal Cancer Screening

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06763432

Start date

Jun 16, 2025

Status verified date

Nov, 2025

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Measurement of Acceptability and Feasibility of a validated survey [ Time Frame: 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 [ Time Frame: From planning to testing and evaluation and assessment of outcomes will be a total of 12 months ]

Central Contacts and Locations

Central contacts

Adjoa Anyane-Yeboa, MD, MPH

617-726-6609aanyane-yeboa@mgh.harvard.edu

Locations

Codman Square Health Center

Recruiting

Boston, Massachusetts, United States, 02124

Contacts

Stephen Tringale Dr. Tringale, MD, MA, FAAFP

617-822-8260Stephen.Tringale@codman.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • colorectal cancer screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-13.