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Use and Decision-making About Colorectal Cancer Screening Among Hispanic Men and Women

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ClinicalTrials.gov Identifier: NCT00136227
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : September 7, 2012
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date September 7, 2012
Study Start Date  ICMJE October 2005
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
colorectal cancer screening initiation rate [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
colorectal cancer screening initiation rate
Change History Complete list of historical versions of study NCT00136227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • decisional balance [ Time Frame: 30 days ]
  • self-efficacy [ Time Frame: 30 days ]
  • knowledge about colorectal cancer screening [ Time Frame: 30 days ]
  • perceived risk of colorectal cancer [ Time Frame: 30 days ]
  • perceived survivability [ Time Frame: 30 days ]
  • perceived guilt [ Time Frame: 30 days ]
  • outcome expectations [ Time Frame: 30 days ]
  • subjective norms [ Time Frame: 30 days ]
  • intention to undergo colorectal cancer screening [ Time Frame: 30 days ]
  • making decisions about colorectal cancer screening that are consistent with their values and preferences [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
  • decisional balance,
  • self efficacy,
  • knowledge about colorectal cancer screening,
  • perceived risk of colorectal cancer,
  • perceived survivability,
  • perceived guilt,
  • outcome expectations,
  • subjective norms,
  • intention to undergo colorectal cancer screening,
  • making decisions about colorectal cancer screening that are consistent with their values and preferences.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use and Decision-making About Colorectal Cancer Screening Among Hispanic Men and Women
Official Title  ICMJE Trial of Interventions to Increase Utilization of Colorectal Cancer Screening and Promote Informed Decision Making About Colorectal Cancer Screening Among Hispanic Men and Women
Brief Summary During this first year, the researchers have worked toward identifying factors influencing initiation of colorectal cancer screening among Hispanic men and women aged 50 and older and developing an intervention plan using Intervention Mapping, a framework for systematic health promotion program planning, implementation, and evaluation. The researchers are also currently in the preliminary stages of developing two promotora (lay health worker)-delivered interventions: a small media intervention (video, flip chart, pamphlets) and a tailored interactive multimedia intervention, prior to the actual collection of data. Thus, although 733 subjects have been approved by the Committee for the Protection of Human Subjects to be enrolled in this study in the future, no subjects have been enrolled at this time. Consequently, there have been no adverse events, and since the risks associated with participating in this study are negligible, the researchers do not anticipate any adverse events in the future. No modifications have been made to the research since the last review, other than that the researchers are currently reassessing the need to conduct preliminary qualitative research as proposed in the original protocol.
Detailed Description During this first year, the researchers have worked toward identifying factors influencing initiation of colorectal cancer screening among Hispanic men and women aged 50 and older and developing an intervention plan using Intervention Mapping, a framework for systematic health promotion program planning, implementation, and evaluation. The researchers are also currently in the preliminary stages of developing two promotora (lay health worker)-delivered interventions: a small media intervention (video, flip chart, pamphlets) and a tailored interactive multimedia intervention, prior to the actual collection of data. Thus, although 733 subjects have been approved by the Committee for the Protection of Human Subjects to be enrolled in this study in the future, no subjects have been enrolled at this time. Consequently, there have been no adverse events, and since the risks associated with participating in this study are negligible, the researchers do not anticipate any adverse events in the future. No modifications have been made to the research since the last review, other than that the researchers are currently reassessing the need to conduct preliminary qualitative research as proposed in the original protocol.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
Study Arms  ICMJE Experimental: Lifestyle counseling
Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
Intervention: Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2012)
521
Original Enrollment  ICMJE
 (submitted: August 25, 2005)
733
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Exclusion Criteria:

  • Personal history of colorectal cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136227
Other Study ID Numbers  ICMJE CDC-NCCDPHP-4527
U48/DP000057 (SIP 18-04)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centers for Disease Control and Prevention
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria E. Fernandez, PhD University of Texas at Houston
PRS Account Centers for Disease Control and Prevention
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP