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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 521
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77225
      • University of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Exclusion Criteria:

• Personal history of colorectal cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
colorectal cancer screening initiation rate	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
decisional balance	30 days
self-efficacy	30 days
knowledge about colorectal cancer screening	30 days
perceived risk of colorectal cancer	30 days
perceived survivability	30 days
perceived guilt	30 days
outcome expectations	30 days
subjective norms	30 days
intention to undergo colorectal cancer screening	30 days
making decisions about colorectal cancer screening that are consistent with their values and preferences	30 days

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Maria E. Fernandez, PhD, University of Texas at Houston

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 25, 2005
• First Submitted That Met QC Criteria: August 25, 2005
• First Posted (Estimate): August 29, 2005

Study Record Updates

• Last Update Posted (Estimate): September 7, 2012
• Last Update Submitted That Met QC Criteria: September 6, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: screening,; community health education,; decision making,; computer-assisted decision making
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDC-NCCDPHP-4527; U48/DP000057 (SIP 18-04)