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Recruiting NCT07345676

Colorectal Cancer Screening Outreach

No phase Interventional Colo-rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bundled messaging intervention.
Who it may be relevant to
Registry conditions: Colo-rectal Cancer. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Number of participants with scheduled or completed colorectal cancer screening. [Time frame: up to 3 months from randomization]
Secondary outcome measures (9)
  • Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy. [Time frame: up to 90 days from intervention]
  • Number of participants who complete screening. [Time frame: up to 90 days from randomization]
  • Number of participants who achieve the primary endpoint. [Time frame: 6 months post randomization]
  • Number of participants who achieve the primary endpoint by message type. [Time frame: up to 90 days from randomization]
  • 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 colonoscopy within 6 months of initial outreach. [Time frame: up to 6 months from initial outreach]
  • Number of participants who provide any response. [Time frame: 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. [Time frame: 6 months post randomization]
  • Number of providers who respond to reminders. [Time frame: 6 months post randomization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Cornell Scott Hill Health — New Haven

Identifiers

NCT: NCT07345676 · 2000041322

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗