- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137618
Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening
March 16, 2010 updated by: Centers for Disease Control and Prevention
Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Univ of Texas - SIP 21-04
This project is a community based participatory research collaboration that will enable increased informed decision making (IDM) for prostate cancer screening in Hispanic and African-American men.
This will be done through the development of an educational program implemented in the communities of El Paso, Texas and Columbia, South Carolina to provide accurate information to men regarding prostate cancer screening in order to enable them to make informed decisions.
Study Overview
Status
Completed
Conditions
Detailed Description
This project is a community based participatory research collaboration among two universities and two research networks that will enable increased Informed Decision Making (IDM) for prostate cancer screening in Hispanic and African American men.
Our collaborating universities are the University of Texas Health Science center at Houston, Texas Prevention Research Center (TPRC), Baylor College of Medicine (BCM), and the University of South Carolina (USC).
Our collaborating networks are the Latinos in a Network for Cancer Control (LINCC), and the South Carolina Cancer Research Network (SC-CRN).
Through the LINCC and the SCCRN, we have been able to link to the Cancer and Chronic Disease Consortium (CCDC, El Paso) which is working with Hispanic communities and the South Carolina Baptist Education and Missionary Convention (BEMC) which is a network of African American churches.
Following the quality criteria for inclusion in evidence reviews conducted by the Community Guide for Preventive Services, we will adapt existing interventions and evaluate the effectiveness of these community-based IDM interventions for prostate cancer screening through two different studies, one at each site.
We will first perform formative qualitative research in Hispanic communities in El Paso, Texas and in African American communities in Columbia, South Carolina.
We will review existing IDM programs and contextual factors pertinent for adoption and dissemination in these two groups.
Using the formative research and the review, we will adapt existing materials for intervention development in each group.
For each study, the interventions will be evaluated using a pre-post-test delayed intervention comparison group design.
As primary outcomes, we will measure the effect of community-based IDM interventions on men's knowledge of prostate cancer screening, participation in screening decisions at their desired level and whether participation was congruent with individual values and preferences in decision-making.
Study Type
Interventional
Enrollment (Anticipated)
264
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina, Arnold School of Public Health
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Texas
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El Paso, Texas, United States, 79902
- UT Houston School of Public Health, El Paso Regional Campus
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Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Males from approximately 40 to 70 years old
Exclusion Criteria:
- Males who have been diagnosed with prostate cancer or other prostate problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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A comparison of pre- and post-test regarding prostate cancer screening knowledge will be assessed quantitatively. The pre-test will be administered before the intervention is implemented and the post-test will be administered immediately following
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Secondary Outcome Measures
Outcome Measure |
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This will include whether or not the participant has decided to have the prostate cancer screening test called prostate specific antigen and if they actually complete it. This will be measured several months after the intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Evelyn Chan, MD, MS, University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
August 26, 2005
First Submitted That Met QC Criteria
August 26, 2005
First Posted (Estimate)
August 30, 2005
Study Record Updates
Last Update Posted (Estimate)
March 18, 2010
Last Update Submitted That Met QC Criteria
March 16, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCCDPHP-2507
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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