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

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.

Conditions

• Colorectal Cancer Screening

Interventions

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.

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.

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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Beverly B Green, MD,MPH · Kaiser Permanente

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• United States

Study Locations