Colorectal Cancer Screening
Conditions
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.
Interventions
BEHAVIORALOutreach
Active: Outreach offering FIT or colonoscopy. Sequential: Outreach offering FIT first, and then offering colonoscopy to those still unscreened
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with screening completion | 6 months from initial offer | Number of patients with FIT or colonoscopy completed |
Countries
United States
Contacts
Primary ContactUri Ladabaum, MD
Outcome results
None listed