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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cancer Prevention Research Institute of Texas
Polymedco Corporation
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01191411
First received: August 27, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer Screening
Other: Mailed invitations for FIT test kits
Other: Mailed invitations for a colonoscopy
Other: Visit Based Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs.

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Colorectal cancer screening participation, defined as completion of a guaiac or immunochemical stool occult blood test, colonoscopy, sigmoidoscopy, or barium enem. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value<0.025 will be considered statistically significant.


Estimated Enrollment: 5780
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mailed inviations for FIT test kits
Fecal Immunochemical Tests from Polymedco are mailed to the patients' homes for a free colorectal cancer screening.
Other: Mailed invitations for FIT test kits
Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
Other Name: Polymedco Fecal Immunochemical Test
Active Comparator: Mailed invitations for a colonoscopy
Patients are mailed an invitation for a free screening colonoscopy.
Other: Mailed invitations for a colonoscopy
These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
Active Comparator: Visit Based Care
Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Other: Visit Based Care
Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.

  Eligibility

Ages Eligible for Study:   54 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    1. FOBT in 2009
    2. Flexible Sigmoidoscopy 2005-09
    3. Barium Enema 2005-09
    4. Colonoscopy 2002-09* Prior history of CRC, inflammatory bowel disease, or colorectal polyps.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191411

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Cancer Prevention Research Institute of Texas
Polymedco Corporation
Investigators
Principal Investigator: Keith Argenbright, MD University of Texas Southwestern Medical Center
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01191411     History of Changes
Other Study ID Numbers: 012011-152
Study First Received: August 27, 2010
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
colorectal neoplasms
screening

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 01, 2014