Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Benefit: Proportion of patients achieving one of the effective screening "successes."
The primary benefit measure will be defined by the proportion of patients achieving an effective screening "success" defined as: Invited to colonoscopy (i.e. colo), responded to invite, determined to be too sick to scope by phone triage and clinical review Screening colo completed, no cancer detected Screening colo completed, cancer detected, 1st cancer treatment consultation visit completed FIT screening completed, test normal, FIT repeated annually for 2 years FIT screening completed, test abnormal, failed phone triage for direct scheduling for colo, and after GI clinic visit, determined to be too sick to scope FIT screening completed, test abnormal, failed phone triage and clinical review, GI clinic visit, determined to be scopable, colo completed FIT screening completed, test abnormal, colo completed, no cancer detected FIT screening completed, test abnormal, colo completed, cancer detected, 1st cancer treatment consultation visit completed
All outcomes will be adjudicated at 40 months post-randomization.
No
Ethan Halm, MD, MPH
Principal Investigator
University of Texas Southwestern Medical Center
United States: Institutional Review Board
102011-069
NCT01710215
April 2013
September 2018
Name | Location |
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Parkland Health & Hospital System | Dallas, Texas 75235 |