Interventions to Improve Colorectal Cancer Screening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00692211
First received: June 3, 2008
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: August 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Colorectal Neoplasms
Interventions: Other: Mailed fecal occult blood tests
Other: Mailed fecal immunochemical tests

  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
Arm 2

Mailed fecal occult blood tests

Fecal occult blood test: Stool blood test

Arm 1

Mailed fecal immunochemical tests

Fecal immunochemical testing: Stool blood test


Participant Flow:   Overall Study
    Arm 2     Arm 1  
STARTED     202     202  
COMPLETED     202     202  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Arm 1

Mailed fecal occult blood tests

Fecal occult blood test: Stool blood test

Arm 2

Mailed fecal immunochemical tests

Fecal immunochemical testing: Stool blood test

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  202     202     404  
Age  
[units: years]
Mean ± Standard Deviation
  63.9  ± 8.1     63.9  ± 7.3     63.9  ± 7.7  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     131     128     259  
>=65 years     71     74     145  
Gender  
[units: participants]
     
Female     9     3     12  
Male     193     199     392  
Region of Enrollment  
[units: participants]
     
United States     202     202     404  



  Outcome Measures

1.  Primary:   Colorectal Cancer Screening   [ Time Frame: 3 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Richard Hoffman, MD
Organization: New Mexico VA Health Care System
phone: 505-265-1711 ext 5318
e-mail: richard.hoffman2@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00692211     History of Changes
Other Study ID Numbers: SHP 08-177
Study First Received: June 3, 2008
Results First Received: August 11, 2014
Last Updated: August 11, 2014
Health Authority: United States: Federal Government