Outreach and Choice in Colorectal Cancer Screening

NCT ID: NCT04940442

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Active choice

FIT or colonoscopy

Group Type: EXPERIMENTAL

Outreach

Intervention Type: BEHAVIORAL

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

Sequential choice

FIT offered first, then colonoscopy offered to those still unscreened

Group Type: EXPERIMENTAL

Outreach

Intervention Type: BEHAVIORAL

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

Interventions

Outreach

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Uri Ladabaum

Professor Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University Primary Care Clinics

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Uri Ladabaum, MD

Role: CONTACT

uri.ladabaum@stanford.edu

6507252850

Facility Contacts

Uri Ladabaum, MD

Role: primary

uri.ladabaum@stanford.edu

650-725-2850

Other Identifiers

61810

Identifier Type: -

Identifier Source: org_study_id