Trial record 10 of 108 for:    (hispanic OR latina) AND (woman OR women OR female)

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • colorectal cancer screening initiation rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 521
Study Start Date: October 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136227

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

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00136227     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-4527, U48/DP000057 (SIP 18-04)
Study First Received: August 25, 2005
Last Updated: September 6, 2012
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014