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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01052922
Enrollment
2260
Registered
2010-01-21
Start date
2009-08-31
Completion date
2011-12-31
Last updated
2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Keywords

Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior

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.

Interventions

OTHER3 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.

OTHER2 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.

OTHER1 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.

Sponsors

Fred Hutchinson Cancer Center
CollaboratorOTHER
University of Washington
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
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.

Design outcomes

Primary

MeasureTime frame
Adherence to FOBT test kit1-2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026