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

This study has been completed.
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Washington
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01052922
First received: January 19, 2010
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer Screening
Other: 3 sample g-SENSA
Other: 2 sample InSure
Other: 1 sample OC-Micron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Adherence to FOBT test kit [ Time Frame: 1-2 months ] [ Designated as safety issue: No ]

Enrollment: 2260
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 sample InSure Other: 2 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.
Active Comparator: 1 sample OC-Micron Other: 1 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.
Active Comparator: 3 sample g-SENSA Other: 3 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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052922

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Fred Hutchinson Cancer Research Center
University of Washington
  More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beverly B. Green, MD, MPH (Principal Investigator), Group Health Research Institute
ClinicalTrials.gov Identifier: NCT01052922     History of Changes
Other Study ID Numbers: 3 R01 CA121125-03S1
Study First Received: January 19, 2010
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Colorectal Neoplasms
Mass Screening
Population Surveillance
Randomized controlled trial
Occult Blood
Colonoscopy
Sigmoidoscopy
Health Behavior

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014