Colorectal Cancer Screening Outreach

Optimizing Evidence-Based Interventions to Improve Colorectal Cancer Screening Adherence in Community Health Clinics

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colo-rectal Cancer
• Intervention / Treatment: Behavioral: Bundled messaging intervention

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilana Richman, MD; Phone Number: 203 737 1024; Email: ilana.richman@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Cornell Scott Hill Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 90-180 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: Bundled messaging intervention; A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.
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).	Behavioral: Bundled messaging intervention; A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.
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).	Behavioral: Bundled messaging intervention; A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy.	Number of participants with abnormal stool-based test who complete a diagnostic colonoscopy within 90 days of intervention.	up to 90 days from intervention
Number of participants who complete screening.	Number of participants who complete screening (stool-based testing or colonoscopy) within 90 days of randomization.	up to 90 days from randomization
Number of participants who achieve the primary endpoint.	Number of participants who achieve the primary endpoint (screening or scheduling of screening) at 6 months post randomization.	6 months post randomization
Number of participants who achieve the primary endpoint by message type.	Number of participants who achieve the primary endpoint (screening scheduling or completion rate at 90 days) by message type (message A/B/C).	up to 90 days from randomization
Number of participants who complete screening within 6 months of initial outreach.	Number of participants who complete screening within 6 months of initial outreach by text message type (message A/B/C).	up to 6 months from initial outreach
Number of participants who complete screening colonoscopy within 6 months of initial outreach.	Number of participants who complete screening colonoscopy within 6 months of initial outreach by text message type (message A/B/C).	up to 6 months from initial outreach
Number of participants who provide any response.	Number of participants who provide any response to text messages by message type (message A/B/C).	7, 14, 21, and 90 days
Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.	Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.	6 months post randomization
Number of providers who respond to reminders.	Number of providers who respond to provider reminders through MyChart message, phone call, or in-clinic discussion.	6 months post randomization

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Ilana Richman, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Screening adherence
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms
• Other Study ID Numbers: 2000041322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No