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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring screening,, community health education,, decision making,, computer-assisted decision making

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Exclusion Criteria: Personal history of colorectal cancer

Sites / Locations

  • University of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

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

Outcomes

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

Full Information

First Posted
August 25, 2005
Last Updated
September 6, 2012
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00136227
Brief Title
Use and Decision-making About Colorectal Cancer Screening Among Hispanic Men and Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
screening,, community health education,, decision making,, computer-assisted decision making

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Behavioral: small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
Intervention Type
Behavioral
Intervention Name(s)
small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention
Primary Outcome Measure Information:
Title
colorectal cancer screening initiation rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
decisional balance
Time Frame
30 days
Title
self-efficacy
Time Frame
30 days
Title
knowledge about colorectal cancer screening
Time Frame
30 days
Title
perceived risk of colorectal cancer
Time Frame
30 days
Title
perceived survivability
Time Frame
30 days
Title
perceived guilt
Time Frame
30 days
Title
outcome expectations
Time Frame
30 days
Title
subjective norms
Time Frame
30 days
Title
intention to undergo colorectal cancer screening
Time Frame
30 days
Title
making decisions about colorectal cancer screening that are consistent with their values and preferences
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion Criteria: Personal history of colorectal cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria E. Fernandez, PhD
Organizational Affiliation
University of Texas at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77225
Country
United States

12. IPD Sharing Statement

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

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