Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments fit screening strategy, colon screening strategy
Sponsor University of Texas Southwestern Medical Center
Collaborator National Institutes of Health (NIH)
Start date April 2013
End date September 2016
Trial size 5999 participants
Trial identifier NCT01710215, 102011-069, 1U54CA163308-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose screening
Arm
(No Intervention)
No outreach mailed invitations. Ordering of colonoscopy or FIT for screening at the discretion of the primary provider. Follow up of abnormal tests and results reporting to the patient at the discretion of primary and specialty providers.
(Experimental)
Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage). Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion. Centralized processes to promote guideline-based follow up.
fit screening strategy
Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage). Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion. Centralized processes to promote guideline-based follow up.
(Experimental)
Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy. Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion. Centralized processes to promote guideline-based follow up.
colon screening strategy
Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy. Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion. Centralized processes to promote guideline-based follow up.

Primary Outcomes

Measure
Benefit: Proportion of patients achieving one of the effective screening "successes."
time frame: All outcomes will be adjudicated at 40 months post-randomization.
Harm: Rate of screening non-participation.
time frame: All outcomes will be adjudicated at 40 months post-randomization.
Cost: Cost per-patient effectively screened.
time frame: All outcomes will be adjudicated at 40 months post-randomization.

Secondary Outcomes

Measure
Benefit: Number of CRCs, advanced adenomas, and adenomas detected.
time frame: All outcomes will be adjudicated at 40 months post-randomization.
Benefit: Number of patients screened.
time frame: All outcomes will be adjudicated at 24 and 40 months post-randomization.
Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening.
time frame: All outcomes will be adjudicated at 40 months post-randomization.
Harm: Ineffective screening.
time frame: All outcomes will be adjudicated at 40 months post-randomization.
Harm: Post-colonoscopy bleeding or perforation.
time frame: All outcomes will be adjudicated at 40 months post-randomization.
Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
time frame: All outcomes will be adjudicated at 40 months post-randomization.
Cost: Cost per patient screened.
time frame: All outcomes will be adjudicated at 24 and 40 months post-randomization.
Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
time frame: All outcomes will be adjudicated at 40 months post-randomization.

Eligibility Criteria

Male or female participants from 50 years up to 64 years old.

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

Additional Information

Official title Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
Principal investigator Amit Singal, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.