Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
NCT ID: NCT01052922
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2260 participants
INTERVENTIONAL
2009-08-31
2011-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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2 sample InSure
2 sample InSure
Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.
1 sample OC-Micron
1 sample OC-Micron
Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.
3 sample g-SENSA
3 sample g-SENSA
Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.
Interventions
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3 sample g-SENSA
Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.
2 sample InSure
Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.
1 sample OC-Micron
Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.
Eligibility Criteria
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Inclusion Criteria
* Continuously enrolled in GHC for 24 months
* Expected to continue to be enrolled at GHC for 24 months
Exclusion Criteria
* History of CRC
* History of inflammatory bowel disease
* Current anticoagulation therapy
* Organ failure
* Serious illness
* Debilitating disease
* Dementia
* Nursing home resident.
50 Years
74 Years
ALL
Yes
Sponsors
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Fred Hutchinson Cancer Center
OTHER
University of Washington
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Beverly B Green, MD,MPH
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Kaiser Permanente Washinton Health Research Institute
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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