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Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies


N/A
50 Years
64 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Outcome Measure:

Benefit: Proportion of patients achieving one of the effective screening "successes."

Outcome Description:

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

Outcome Time Frame:

All outcomes will be adjudicated at 40 months post-randomization.

Safety Issue:

No

Principal Investigator

Ethan Halm, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center

Authority:

United States: Institutional Review Board

Study ID:

102011-069

NCT ID:

NCT01710215

Start Date:

April 2013

Completion Date:

September 2018

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms
  • Colorectal Cancer
  • Colon Cancer
  • Mass Screening
  • Health Services Research
  • Comparative Effectiveness Research
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Parkland Health & Hospital SystemDallas, Texas  75235