Health TrialsbyHealthPanel

Colorectal Cancer Screening Outreach

ConditionColo-rectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorYale University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bundled messaging intervention

    Behavioral

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

Treatment groups

2,000 Participants
are divided into 4 treatment groups
Group A: Control-Usual CareNo intervention 0 interventions
Group B: Messaging Group AExperimental treatment 1 intervention
Group C: Messaging Group BExperimental treatment 1 intervention
Group D: Messaging Group CExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
up to 3 months from randomization

Secondary outcomes

1

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.

Time frame
up to 90 days from intervention
2

Number of participants who complete screening.

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

Time frame
up to 90 days from randomization
3

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.

Time frame
6 months post randomization
4

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).

Time frame
up to 90 days from randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Source ClinicalTrials.gov
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