- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01710215
Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
April 25, 2018 updated by: University of Texas Southwestern Medical Center
Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening.
However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum.
Modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up--something never achieved in clinical practice.
Comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary.
Safety-net health systems care for populations at increased risk for adverse CRC outcomes, such as the uninsured and minorities, and have more limited resources.
Therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy.
The investigators will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net health system.
The three strategies studied will be: 1) Fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at primary care visits.
The primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening successes.
The primary measure of harm will be screening non-participation.
The primary measure of cost will be cost per-patient effectively screened.
Our specific aims are to: 1) Compare benefits, harms, and costs of a FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care and b) the Colo strategy vs. Usual Care for CRC screening.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5999
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
-
Dallas, Texas, United States, 75235
- Parkland Health & Hospital System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females
- Age 50-64 years
- Seen one or more times at a Parkland primary care clinic within one year (Index Year)
- Participants in Parkland's medical assistance program for the uninsured (Parkland Health Plus)
- All races and ethnicities
Exclusion Criteria:
Up-to-date with CRC screening, defined by:
- Colonoscopy in the last 10 years
- Sigmoidoscopy in the last 5 years
- Stool blood test (FIT) in the last year
- Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps
- Address or phone number not on file
- Incarcerated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
Experimental: FIT Screening Strategy
|
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Experimental: Colon Screening Strategy
|
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Benefit: Proportion of patients achieving one of the effective screening "successes."
Time Frame: All outcomes will be adjudicated within 3 years.
|
The primary benefit measure will be defined by the proportion of patients achieving an effective screening "success" defined as:
|
All outcomes will be adjudicated within 3 years.
|
Harm: Rate of screening non-participation.
Time Frame: All outcomes will be adjudicated within 3 years.
|
The primary measure of harms will be the rate of non-screening because initial test completion is a basic prerequisite for prevention of adverse CRC outcomes by a screening process.
It is a readily measurable, basic quality assessment.
Processes associated with high rates of non-screening would be expected to result in poor long term CRC outcomes.
|
All outcomes will be adjudicated within 3 years.
|
Cost: Cost per-patient effectively screened.
Time Frame: All outcomes will be adjudicated within 3 years.
|
The primary measure of costs will be the cost per-patient effectively screened from the health system perspective, with effective screening defined by the proportion of patients achieving an effective screening "success."
Follow up time for cost-assessment will start at randomization and end either when a patient reaches an effective screening "success" endpoint, or at the end of the three year-follow up time.
This outcome addresses a practical question most health systems will have in assessing our screening strategy: What is the strategy specific cost per-patient effectively screened?
|
All outcomes will be adjudicated within 3 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Benefit: Number of CRCs, advanced adenomas, and adenomas detected.
Time Frame: All outcomes will be adjudicated within 3 years.
|
Number of CRCs, advanced adenomas, and adenomas detected.
|
All outcomes will be adjudicated within 3 years.
|
Benefit: Number of patients screened.
Time Frame: All outcomes will be adjudicated within 3 years.
|
Number of patients screened, defined by the proportion of patients completing one time FIT or colonoscopy.
|
All outcomes will be adjudicated within 3 years.
|
Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening.
Time Frame: All outcomes will be adjudicated within 3 years.
|
Number of CRCs diagnosed based on symptoms/signs rather than screening.
|
All outcomes will be adjudicated within 3 years.
|
Harm: Ineffective screening.
Time Frame: All outcomes will be adjudicated within 3 years.
|
Not achieving an effective screening "success."
See definition of effective screening "successes" above.
|
All outcomes will be adjudicated within 3 years.
|
Harm: Post-colonoscopy bleeding or perforation.
Time Frame: All outcomes will be adjudicated within 3 years.
|
Post-colonoscopy bleeding or perforation.
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All outcomes will be adjudicated within 3 years.
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Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
Time Frame: All outcomes will be adjudicated within 3 years.
|
Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
|
All outcomes will be adjudicated within 3 years.
|
Cost: Cost per patient screened.
Time Frame: All outcomes will be adjudicated within 3 years.
|
Cost per patient screened.
|
All outcomes will be adjudicated within 3 years.
|
Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
Time Frame: All outcomes will be adjudicated within 3 years.
|
Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
|
All outcomes will be adjudicated within 3 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Amit Singal, MD, University of Texas Southwestern Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
October 5, 2012
First Submitted That Met QC Criteria
October 18, 2012
First Posted (Estimate)
October 19, 2012
Study Record Updates
Last Update Posted (Actual)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 25, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102011-069
- 1U54CA163308-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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