NCT01052922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

January 19, 2010

Last Update Submit

October 11, 2017

Conditions

Colorectal Cancer Screening

Keywords

Colorectal NeoplasmsMass ScreeningPopulation SurveillanceRandomized controlled trialOccult BloodColonoscopySigmoidoscopyHealth Behavior

Outcome Measures

Primary Outcomes (1)

  • Adherence to FOBT test kit

    1-2 months

Study Arms (3)

2 sample InSure

ACTIVE COMPARATOR
Other: 2 sample InSure

1 sample OC-Micron

ACTIVE COMPARATOR
Other: 1 sample OC-Micron

3 sample g-SENSA

ACTIVE COMPARATOR
Other: 3 sample g-SENSA

Interventions

3 sample g-SENSAOTHER

Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.

3 sample g-SENSA
2 sample InSureOTHER

Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.

2 sample InSure
1 sample OC-MicronOTHER

Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.

1 sample OC-Micron

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not up to date on CRCS
  • Continuously enrolled in GHC for 24 months
  • Expected to continue to be enrolled at GHC for 24 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Washinton Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Chubak J, Bogart A, Fuller S, Laing SS, Green BB. Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial. Prev Med. 2013 Nov;57(5):671-8. doi: 10.1016/j.ypmed.2013.08.032. Epub 2013 Sep 9.

    PMID: 24029556DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsHealth Behavior

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Study Officials

  • Beverly B Green, MD,MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)