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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136227
• Other study ID #: CDC-NCCDPHP-4527
• Secondary ID: U48/DP000057 (SI
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: September 6, 2012
• Start date: October 2005
• Est. completion date: April 2010

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Exclusion Criteria:

• Personal history of colorectal cancer

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colorectal cancer screening initiation rate		30 days	No
Secondary	decisional balance		30 days	No
Secondary	self-efficacy		30 days	No
Secondary	knowledge about colorectal cancer screening		30 days	No
Secondary	perceived risk of colorectal cancer		30 days	No
Secondary	perceived survivability		30 days	No
Secondary	perceived guilt		30 days	No
Secondary	outcome expectations		30 days	No
Secondary	subjective norms		30 days	No
Secondary	intention to undergo colorectal cancer screening		30 days	No
Secondary	making decisions about colorectal cancer screening that are consistent with their values and preferences		30 days	No