Outreach and Choice in Colorectal Cancer Screening

NCT04940442 | Unknown

• 1 other identifier: 61810
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Number of patients with screening completion

  Number of patients with FIT or colonoscopy completed

  6 months from initial offer

Study Arms (2)

Active choice

EXPERIMENTAL

FIT or colonoscopy

Behavioral: Outreach

Sequential choice

EXPERIMENTAL

FIT offered first, then colonoscopy offered to those still unscreened

Behavioral: Outreach

Interventions

Outreach BEHAVIORAL

Active: Outreach offering FIT or colonoscopy. Sequential: Outreach offering FIT first, and then offering colonoscopy to those still unscreened

Active choice; Sequential choice

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Primary Care Clinics

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Interventions

Community-Institutional Relations

Intervention Hierarchy (Ancestors)

Public Relations; Organization and Administration; Health Services Administration

Central Study Contacts

Uri Ladabaum, MD

CONTACT

6507252850; uri.ladabaum@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Medicine

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 27, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)