Clinical trial NCT00136227: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: screening,
community health education,
decision making,
computer-assisted decision making
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-08-29
Enrollment: 521
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Exclusion Criteria:

* Personal history of colorectal cancer

Primary outcomes:
measure: colorectal cancer screening initiation rate
timeFrame: 30 days
Secondary outcomes:
measure: decisional balance
timeFrame: 30 days
measure: self-efficacy
timeFrame: 30 days
measure: knowledge about colorectal cancer screening
timeFrame: 30 days
measure: perceived risk of colorectal cancer
timeFrame: 30 days
measure: perceived survivability
timeFrame: 30 days
measure: perceived guilt
timeFrame: 30 days
measure: outcome expectations
timeFrame: 30 days
measure: subjective norms
timeFrame: 30 days
measure: intention to undergo colorectal cancer screening
timeFrame: 30 days
measure: making decisions about colorectal cancer screening that are consistent with their values and preferences
timeFrame: 30 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: University of Texas at Houston
name: Maria E. Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: