Clinical trial NCT01710215: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
Official title: Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Neoplasms
Colorectal Cancer
Colon Cancer
Mass Screening
Health Services Research
Comparative Effectiveness Research
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: Parkland Health and Hospital System
First posted: 2012-10-19
Enrollment: 5999
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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:

  1. Colonoscopy in the last 10 years
  2. Sigmoidoscopy in the last 5 years
  3. 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

Primary outcomes:
measure: Benefit: Proportion of patients achieving one of the effective screening "successes."
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Harm: Rate of screening non-participation.
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Cost: Cost per-patient effectively screened.
timeFrame: All outcomes will be adjudicated within 3 years.
Secondary outcomes:
measure: Benefit: Number of CRCs, advanced adenomas, and adenomas detected.
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Benefit: Number of patients screened.
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening.
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Harm: Ineffective screening.
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Harm: Post-colonoscopy bleeding or perforation.
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Cost: Cost per patient screened.
timeFrame: All outcomes will be adjudicated within 3 years.
measure: Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
timeFrame: All outcomes will be adjudicated within 3 years.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Amit Singal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.