Outreach and Choice in Colorectal Cancer Screening

Stanford University

Status: Unknown

Conditions: Colorectal Cancer Screening

Treatments: Behavioral: Outreach

Study type: Interventional

Funder types: Other

Identifiers

NCT04940442

61810

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5,000 participants in 2 patient groups

Active choice

Experimental group

Description:

FIT or colonoscopy

Treatment:

Behavioral: Outreach

Sequential choice

Experimental group

Description:

FIT offered first, then colonoscopy offered to those still unscreened

Treatment:

Behavioral: Outreach