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N/A N=5,970 Randomized Quadruple-blind Health Services Research

Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs

Colorectal Cancer

Enrolled (actual)
5,970
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem. — 40.7; 24.6; 12.1; 38.7 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Mailed invitations for FIT test kits (Other); Mailed invitations for a colonoscopy (Other); Visit Based Care (Other)
Age
Adult · 54+ yrs
Sex
All
Sponsor
University of Texas Southwestern Medical Center
Primary completion
Sep 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
40.7; 24.6; 12.1; 38.7; 23.3; 10.7

Summary

Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations such as those with limited or no health insurance. This striking public health challenge demands urgent implementation of evidence-based strategies to reduce avoidable CRC death. Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to complete CRC screening may result in increased rates of screening completion. However, this approach has not been tested extensively in vulnerable populations, such as the under/uninsured, and minority populations often cared for by safety-net health systems. Further, it is unclear whether patients are more likely to participate in one CRC screening test versus another. Knowing this is important to designing programs for increasing screening. For example, the planning and resources required for a screening program with colonoscopy--which is a sensitive but invasive and expensive test--are very different from a program with that uses stool testing to detect microscopic blood such as an immunochemical stool blood test--which is a less sensitive, but non-invasive and cheap test. Also, it is possible designing a program with a less sensitive, but more acceptable test could prevent more CRC death if participation in screening is test specific. For example, if many more patients participate in an immunochemical stool blood test based program than a colonoscopy based program, even though the immunochemical stool blood test is less sensitive, the program may save more lives because more patients are reached. The aims of this trial are to: Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders, and systematic clinical follow up) to uninsured, unscreened patients cared for by the safety-net health system serving Tarrant County, Texas. Patients will be invited to either: 1. Complete a free home-based, non-invasive immunochemical stool blood test 2. Complete a free colonoscopy Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program costs. The primary outcome is screening completion.

Eligibility Criteria

Inclusion Criteria

  • 54 to 64 year old men and women
  • All races and ethnicities
  • Patients that have been on JPS Connection in 2010 or JPS Connection in 2009 and have been seen at least once between September 1, 2009 and August 31, 2010 in any JPS setting

Exclusion Criteria

  • No address and phone number on file
  • Incarcerated individuals
  • Primary language other than English or Spanish
  • Up to date with CRC screening, defined as any:
  • Fecal Occult Blood Test (FOBT) in 2009
  • Flexible Sigmoidoscopy 2005-09
  • Barium Enema 2005-09
  • Colonoscopy 2002-09* Prior history of CRC, inflammatory bowel disease, or colorectal polyps.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01191411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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