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Recruiting

NCT Number: NCT07345676

Colorectal Cancer Screening Outreach

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

Recruiting

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cornell Scott Hill Health

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bundled messaging intervention

Behavioral

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

Primary outcomes

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

    Time frame: up to 3 months from randomization

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

Secondary outcomes

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

    Time frame: up to 90 days from intervention

    Number of participants with abnormal stool-based test who complete a diagnostic colonoscopy within 90 days of intervention.

  2. Number of participants who complete screening.

    Time frame: up to 90 days from randomization

    Number of participants who complete screening (stool-based testing or colonoscopy) within 90 days of randomization.

  3. Number of participants who achieve the primary endpoint.

    Time frame: 6 months post randomization

    Number of participants who achieve the primary endpoint (screening or scheduling of screening) at 6 months post randomization.

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

    Time frame: up to 90 days from randomization

    Number of participants who achieve the primary endpoint (screening scheduling or completion rate at 90 days) by message type (message A/B/C).

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

    Time frame: up to 6 months from initial outreach

    Number of participants who complete screening within 6 months of initial outreach by text message type (message A/B/C).

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

    Time frame: up to 6 months from initial outreach

    Number of participants who complete screening colonoscopy within 6 months of initial outreach by text message type (message A/B/C).

  7. Number of participants who provide any response.

    Time frame: 7, 14, 21, and 90 days

    Number of participants who provide any response to text messages by message type (message A/B/C).

  8. Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.

    Time frame: 6 months post randomization

    Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.

  9. Number of providers who respond to reminders.

    Time frame: 6 months post randomization

    Number of providers who respond to provider reminders through MyChart message, phone call, or in-clinic discussion.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilana Richman, MD

CONTACT

[email protected]

203 737 1024

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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