Outreach and Choice in Colorectal Cancer Screening

Not Applicable

• Conditions: Colorectal Cancer Screening
• Interventions: Behavioral: Outreach

• Registration Number: NCT04940442
• Lead Sponsor: Stanford University

Brief Summary

The primary objective of this clinical trial will be to compare overall colorectal cancer (CRC) screening participation between an active choice (fecal immunochemical test \[FIT\] or colonoscopy) and a sequential choice (FIT offered first, then colonoscoscopy offered in those still unscreened) arm. Secondarily, we will (1) compare the proportions of FIT vs. colonoscopy per arm, (2) compare active choice vs FIT only in the initial 3 months of the study, (3) characterize changes in physician knowledge and attitudes regarding CRC screening before and after an educational seminar delivered at the launch of the initiative, (4) characterize perceptions regarding the effect of the intervention on clinical practices, and (5) compare detection rates of CRC, adenomas and SSLs per arm, and the operational results of the outreach program across arms.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Study Start: 2021-08-01
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. Adults 45-75 years of age not up to date with CRC screening, and without precancerous polyp history (i.e. not in post-polypectomy surveillance; ascertained based on problem list or colonoscopy results letter).

2. The assessment of screening status will happen monthly, on a rolling basis.

3. Definition of being up to date with CRC screening includes any one of the following:

   i) FIT or guaiac-FOBT within 1 year, OR

ii) Colonoscopy within 10 years, OR

iii) Sigmoidoscopy within 5 years, OR

iv) CT colonography within 5 years, OR

v) Cologuard within 3 years

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Exclusion Criteria

1. Age outside the 45-75 range.
2. History of precancerous polyps requiring colonoscopy surveillance.
3. Already being up to date with CRC screening, as defined above.
4. Evidence of total removal of the colon which would eliminate the need for screening.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active choice	Outreach	FIT or colonoscopy
Sequential choice	Outreach	FIT offered first, then colonoscopy offered to those still unscreened

Primary Outcome Measures

Name	Time	Method
Number of patients with screening completion	6 months from initial offer	Number of patients with FIT or colonoscopy completed

Trial Locations

Locations (1)

Stanford University Primary Care Clinics; 🇺🇸 Palo Alto, California, United States