Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
Primary Purpose
Colorectal Cancer Screening
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3 sample g-SENSA
2 sample InSure
1 sample OC-Micron
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer Screening focused on measuring Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior
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.
Sites / Locations
- Kaiser Permanente Washinton Health Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
2 sample InSure
1 sample OC-Micron
3 sample g-SENSA
Arm Description
Outcomes
Primary Outcome Measures
Adherence to FOBT test kit
Secondary Outcome Measures
Full Information
NCT ID
NCT01052922
First Posted
January 19, 2010
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
Fred Hutchinson Cancer Center, University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT01052922
Brief Title
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Fred Hutchinson Cancer Center, University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 sample InSure
Arm Type
Active Comparator
Arm Title
1 sample OC-Micron
Arm Type
Active Comparator
Arm Title
3 sample g-SENSA
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
3 sample g-SENSA
Intervention Description
Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.
Intervention Type
Other
Intervention Name(s)
2 sample InSure
Intervention Description
Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.
Intervention Type
Other
Intervention Name(s)
1 sample OC-Micron
Intervention Description
Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.
Primary Outcome Measure Information:
Title
Adherence to FOBT test kit
Time Frame
1-2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly B Green, MD,MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Washinton Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24029556
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.
Results Reference
derived
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Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
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