Recruiting

Colorectal Cancer Screening

Sponsor:

Stanford University

Code:

NCT04940442

Conditions

Colorectal Cancer Screening

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Outreach

Study Details

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 ID

NCT04940442

Start date

Aug 1, 2021

Status verified date

Jun, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Active choice

FIT or colonoscopy

experimental: Sequential choice

FIT offered first, then colonoscopy offered 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

Primary outcome measure

  • Number of patients with screening completion [ Time Frame: 6 months from initial offer ]

Central Contacts and Locations

Central contacts

Uri Ladabaum, MD

6507252850uri.ladabaum@stanford.edu

Locations

Stanford University Primary Care Clinics

Recruiting

Palo Alto, California, United States, 94305

Contacts

Uri Ladabaum, MD

650-725-2850uri.ladabaum@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Sep 27, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2021-09-27.