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Use and Decision-Making About Colorectal Cancer Screening Among Hispanic Men and Women
This study is not yet open for participant recruitment.
Verified by Centers for Disease Control and Prevention, August 2005
Sponsored by: Centers for Disease Control and Prevention
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00136227
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
Phase III

MedlinePlus related topics: Cancer Colorectal Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Trial of Interventions to Increase Utilization of Colorectal Cancer Screening and Promote Informed Decision Making About Colorectal Cancer Screening Among Hispanic Men and Women

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • colorectal cancer screening initiation rate

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 733
Study Start Date: October 2005
Estimated Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Exclusion Criteria:

  • Personal history of colorectal cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136227

Contacts
Contact: Maria E. Fernandez, PhD (713)500-9626 Maria.E.Fernandez@uth.tmc.edu

Locations
United States, Texas
University of Texas
Houston, Texas, United States, 77225
Sponsors and Collaborators
Investigators
Principal Investigator: Maria E. Fernandez, PhD University of Texas at Houston
  More Information

Study ID Numbers: CDC-NCCDPHP-4527, U48/DP000057 (SIP 18-04)
Study First Received: August 25, 2005
Last Updated: December 12, 2005
ClinicalTrials.gov Identifier: NCT00136227  
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
screening,
community health education,
decision making,
computer-assisted decision making

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009