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Clinical Trials/NCT01052922
NCT01052922CompletedNot Applicable

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

Kaiser Permanente1 site in 1 country2,260 target enrollmentStarted: August 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,260
Locations
1
Primary Endpoint
Adherence to FOBT test kit

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
50 Years to 74 Years (Adult, Older Adult)
Sex
All
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
  • •Nursing home resident.

Arms & Interventions

3 sample g-SENSA

Active Comparator

Intervention: 3 sample g-SENSA (Other)

2 sample InSure

Active Comparator

Intervention: 2 sample InSure (Other)

1 sample OC-Micron

Active Comparator

Intervention: 1 sample OC-Micron (Other)

Outcomes

Primary Outcomes

Adherence to FOBT test kit

Time Frame: 1-2 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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