Outreach and Choice in Colorectal Cancer Screening

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: Outreach

• Study Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uri Ladabaum, MD; Phone Number: 6507252850; Email: uri.ladabaum@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford University Primary Care Clinics
      • Contact: Uri Ladabaum, MD; Phone Number: 650-725-2850; Email: uri.ladabaum@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active choice; FIT or colonoscopy	Behavioral: Outreach; Active: Outreach offering FIT or colonoscopy. Sequential: Outreach offering FIT first, and then offering colonoscopy to those still unscreened
Experimental: Sequential choice; FIT offered first, then colonoscopy offered to those still unscreened	Behavioral: Outreach; Active: Outreach offering FIT or colonoscopy. Sequential: Outreach offering FIT first, and then offering colonoscopy to those still unscreened

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with screening completion	Number of patients with FIT or colonoscopy completed	6 months from initial offer

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 61810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No