Clinical trial · Interventional
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1 sample OC-Micron | Other | — | UNRESOLVED |
| 2 sample InSure | Other | — | UNRESOLVED |
| 3 sample g-SENSA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 2 sample InSure
- interventionNames
- Other: 2 sample InSure
- type
- ACTIVE_COMPARATOR
- label
- 1 sample OC-Micron
- interventionNames
- Other: 1 sample OC-Micron
- type
- ACTIVE_COMPARATOR
- label
- 3 sample g-SENSA
- interventionNames
- Other: 3 sample g-SENSA
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDChubak 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. PMID 24029556