Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01052922|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : October 13, 2017
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer Screening||Other: 3 sample g-SENSA Other: 2 sample InSure Other: 1 sample OC-Micron||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
|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.
- Adherence to FOBT test kit [ Time Frame: 1-2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052922
|United States, Washington|
|Kaiser Permanente Washinton Health Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Beverly B Green, MD,MPH||Kaiser Permanente|