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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00136227
First received: August 25, 2005
Last updated: September 6, 2012
Last verified: September 2012

August 25, 2005
September 6, 2012
October 2005
April 2010   (final data collection date for primary outcome measure)
colorectal cancer screening initiation rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
colorectal cancer screening initiation rate
Complete list of historical versions of study NCT00136227 on ClinicalTrials.gov Archive Site
  • decisional balance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • self-efficacy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • knowledge about colorectal cancer screening [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • perceived risk of colorectal cancer [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • perceived survivability [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • perceived guilt [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • outcome expectations [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • subjective norms [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • intention to undergo colorectal cancer screening [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • making decisions about colorectal cancer screening that are consistent with their values and preferences [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Use and Decision-making About Colorectal Cancer Screening Among Hispanic Men and Women
Trial of Interventions to Increase Utilization of Colorectal Cancer Screening and Promote Informed Decision Making About Colorectal Cancer Screening Among Hispanic Men and Women

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Colorectal Cancer
Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
521
April 2010
April 2010   (final data collection date for primary outcome measure)

Exclusion Criteria:

  • Personal history of colorectal cancer
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00136227
CDC-NCCDPHP-4527, U48/DP000057 (SIP 18-04)
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: Maria E. Fernandez, PhD University of Texas at Houston
Centers for Disease Control and Prevention
September 2012

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