Recruiting

Colorectal Cancer Screening

Sponsor:

Yale University

Code:

NCT07345676

Conditions

Colo-rectal Cancer

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Bundled messaging intervention

Study Details

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

Study ID

NCT07345676

Start date

Jun 23, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 90-365 days prior to randomization.

OR

  • 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.

Exclusion Criteria:

  • Because this is a pragmatic study of a behavioral intervention to improve colorectal cancer screening adherence, any participants who otherwise meet the inclusion criteria will not be excluded.

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Control-Usual Care

Participants will receive a simple text message reminder

experimental: Messaging Group A

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).

experimental: Messaging Group B

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).

experimental: Messaging Group C

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).

Interventions

Bundled messaging intervention

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

Primary outcome measure

  • Number of participants with scheduled or completed colorectal cancer screening. [ Time Frame: up to 3 months from randomization ]

Central Contacts and Locations

Central contacts

Locations

Cornell Scott Hill Health

Recruiting

New Haven, Connecticut, United States, 06519

More Information

Sponsor

Yale University

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Screening adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-07.