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

Colorectal Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052922
• Other study ID #: 3R01CA121125-03S1
• Status: Completed
• Phase: N/A
• First received: January 19, 2010
• Last updated: October 11, 2017
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2260
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washinton Health Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	Fred Hutchinson Cancer Research Center, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to FOBT test kit		1-2 months