Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Screening |
Other: 3 sample g-SENSA Other: 2 sample InSure Other: 1 sample OC-Micron |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement |
- Adherence to FOBT test kit [ Time Frame: 1-2 months ] [ Designated as safety issue: No ]
| Enrollment: | 2260 |
| Study Start Date: | August 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2 sample InSure |
Other: 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.
|
| Active Comparator: 1 sample OC-Micron |
Other: 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.
|
| Active Comparator: 3 sample g-SENSA |
Other: 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.
|
Eligibility| Ages Eligible for Study: | 50 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Washington | |
| Group Health Research Institute | |
| Seattle, Washington, United States, 98101 | |
More Information
No publications provided
| Responsible Party: | Beverly B. Green, MD, MPH (Principal Investigator), Group Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01052922 History of Changes |
| Other Study ID Numbers: | 3 R01 CA121125-03S1 |
| Study First Received: | January 19, 2010 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Group Health Cooperative:
|
Colorectal Neoplasms Mass Screening Population Surveillance Randomized controlled trial |
Occult Blood Colonoscopy Sigmoidoscopy Health Behavior |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013