Clinical trial NCT01052922: Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
Official title: Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: Colorectal Neoplasms
Mass Screening
Population Surveillance
Randomized controlled trial
Occult Blood
Colonoscopy
Sigmoidoscopy
Health Behavior
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: University of Washington
First posted: 2010-01-21
Enrollment: 2260
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to FOBT test kit
timeFrame: 1-2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washinton Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Beverly B Green, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chubak J, Bogart A, Fuller S, Laing SS, Green BB. Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial. Prev Med. 2013 Nov;57(5):671-8. doi: 10.1016/j.ypmed.2013.08.032. Epub 2013 Sep 9.