Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement

Study Overview
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Brief Summary
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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.

Official Title
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Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement

Conditions
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Colorectal Cancer Screening

Intervention / Treatment
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* Other: 3 sample g-SENSA
* Other: 2 sample InSure
* Other: 1 sample OC-Micron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 sample InSure<br> | Other: 2 sample InSure<br>* Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.<br>|
| Active Comparator: 1 sample OC-Micron<br> | Other: 1 sample OC-Micron<br>* Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.<br>|
| Active Comparator: 3 sample g-SENSA<br> | Other: 3 sample g-SENSA<br>* Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to FOBT test kit |  | 1-2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior