Colorectal Cancer Screening
Conditions
Keywords
Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior
Brief summary
Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the first time since randomization to have CRCS, either based on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons between groups, but also over time. Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study aims. First, we will enroll patients age 50-74 years using the same criteria as for the primary SOS study, which includes neither history of colorectal cancer nor evidence of life-limiting disease. Participants who return the questionnaire, consent and considered eligible will be randomized to receive one of three different at-home fecal test kits. The kits will be returned to the GH centralized laboratory, and participants will be informed about lab results using standard GH pathways. Participants who have a test-positive will receive a series of two follow-up surveys (first at 1-2 weeks post result and second at 4-months post result). A comparison group of test-negative results will be matched based on selected criteria, and this group will also receive the follow-up surveys. Participants at both time intervals who do not return the survey via mail will be called and if available, administered the questionnaire via phone.
Interventions
Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.
Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.
Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.
Sponsors
Study design
Eligibility
Inclusion criteria
* Not up to date on CRCS * Continuously enrolled in GHC for 24 months * Expected to continue to be enrolled at GHC for 24 months
Exclusion criteria
* Known high risk for CRC * History of CRC * History of inflammatory bowel disease * Current anticoagulation therapy * Organ failure * Serious illness * Debilitating disease * Dementia * Nursing home resident.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to FOBT test kit | 1-2 months |
Countries
United States