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

Kaiser Permanente

Status: Completed

Conditions: Colorectal Cancer Screening

Treatments: Other: 2 sample InSure; Other: 1 sample OC-Micron; Other: 3 sample g-SENSA

Study type: Interventional

Funder types: Other

Identifiers

NCT01052922

3R01CA121125-03S1

Details and patient eligibility

About

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.

Enrollment: 2,260 patients

Sex: All

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,260 participants in 3 patient groups

2 sample InSure

Active Comparator group

Treatment:

Other: 2 sample InSure

1 sample OC-Micron

Active Comparator group

Treatment:

Other: 1 sample OC-Micron

3 sample g-SENSA

Active Comparator group

Treatment:

Other: 3 sample g-SENSA