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Clinical Trials/NCT04940442
NCT04940442
Unknown
Not Applicable

Outreach and Choice in Colorectal Cancer Screening

Stanford University1 site in 1 country5,000 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer Screening
Sponsor
Stanford University
Enrollment
5000
Locations
1
Primary Endpoint
Number of patients with screening completion
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Uri Ladabaum

Professor Medicine

Stanford University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number of patients with screening completion

Time Frame: 6 months from initial offer

Number of patients with FIT or colonoscopy completed

Study Sites (1)

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