Colorectal Cancer Screening Outreach

NCT07345676 | Not Yet Recruiting

• 1 other identifier: 2000041322
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.

Conditions

Colo-rectal Cancer

Keywords

Screening adherence

Outcome Measures

Primary Outcomes (1)

• Number of participants with scheduled or completed colorectal cancer screening.

  Number of participants who completed or scheduled screening (colonoscopy or stool-based test) within 3 months of randomization.

  up to 3 months from randomization

Secondary Outcomes (9)

• Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy.

  up to 90 days from intervention

• Number of participants who complete screening.

  up to 90 days from randomization

• Number of participants who achieve the primary endpoint.

  6 months post randomization

• Number of participants who achieve the primary endpoint by message type.

  up to 90 days from randomization

• Number of participants who complete screening within 6 months of initial outreach.

  up to 6 months from initial outreach

Study Arms (4)

Control-Usual Care

NO INTERVENTION

Participants will receive a simple text message reminder

Messaging Group A

EXPERIMENTAL

Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C).

Behavioral: Bundled messaging intervention

Messaging Group B

EXPERIMENTAL

Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C).

Behavioral: Bundled messaging intervention

Messaging Group C

EXPERIMENTAL

Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C).

Behavioral: Bundled messaging intervention

Interventions

Bundled messaging intervention BEHAVIORAL

A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.

Messaging Group A; Messaging Group B; Messaging Group C

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or \>1 adult medicine visits in the last year).
• Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-180 days prior to randomization.
• Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Cornell Scott Hill Health

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ilana Richman, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilana Richman, MD

CONTACT

203 737 1024; ilana.richman@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will include adults who receive care at a local, multisite federally qualified health center, who have outstanding orders for colorectal cancer screening.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)