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

This study has been completed.
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: October 13, 2014
Last verified: September 2014
Results First Received: October 13, 2014  
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
Condition: Colorectal Cancer
Interventions: Other: Mailed invitations for FIT test kits
Other: Mailed invitations for a colonoscopy
Other: Visit Based Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mailed Invitations for FIT Test Kits

Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.

Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.

Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.

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.

Mailed Invitations for a Colonoscopy

Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.

Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.

Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.

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.

Visit Based Care

No invitation to complete colorectal cancer screening.

Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.

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.


Participant Flow:   Overall Study
    Mailed Invitations for FIT Test Kits     Mailed Invitations for a Colonoscopy     Visit Based Care  
STARTED     1593     479     3898  
COMPLETED     648     118     471  
NOT COMPLETED     945     361     3427  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Men and women, aged 54 to 64 years, who were uninsured but enrolled in the JPS medical assistance program for the uninsured. Not up-to-date with colorectal cancer screening; no history of colorectal cancer, inflammatory bowel disease, or colorectal polyps.

Reporting Groups
  Description
Mailed Invitations for FIT Test Kits

Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.

Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.

Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.

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.

Mailed Invitations for a Colonoscopy

Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.

Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.

Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.

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.

Visit Based Care

No invitation to complete colorectal cancer screening.

Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.

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.

Total Total of all reporting groups

Baseline Measures
    Mailed Invitations for FIT Test Kits     Mailed Invitations for a Colonoscopy     Visit Based Care     Total  
Number of Participants  
[units: participants]
  1593     479     3898     5970  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 3     59  ± 3     59  ± 3     59  ± 3  
Gender  
[units: participants]
       
Female     993     286     2517     3796  
Male     600     193     1381     2174  
Race/Ethnicity, Customized  
[units: participants]
       
White     653     195     1600     2448  
Black     370     128     913     1411  
Hispanic     445     122     1140     1707  
Other     125     34     245     404  
Study-Specific Measure  
[units: participants]
       
English     1322     410     3253     4985  
Spanish     271     69     645     985  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Keith E. Argenbright, MD
Organization: University of Texas Southwestern Medical Center
phone: 817-288-9898
e-mail: keith.argenbright@utsouthwestern.edu


No publications provided by University of Texas Southwestern Medical Center

Publications automatically indexed to this study:

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
Results First Received: October 13, 2014
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board