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Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137618
First Posted: August 30, 2005
Last Update Posted: March 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by:
Centers for Disease Control and Prevention
  Purpose
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.

Condition Intervention
Prostate Cancer Behavioral: Educational Intervention to Increase Informed Decision Making for Prostate Cancer Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Univ of Texas - SIP 21-04

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 264
Study Start Date: November 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males from approximately 40 to 70 years old

Exclusion Criteria:

  • Males who have been diagnosed with prostate cancer or other prostate problems
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137618


Locations
United States, South Carolina
University of South Carolina, Arnold School of Public Health
Columbia, South Carolina, United States, 29208
United States, Texas
UT Houston School of Public Health, El Paso Regional Campus
El Paso, Texas, United States, 79902
University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research
Houston, Texas, United States, 77030
Sponsors and Collaborators
Centers for Disease Control and Prevention
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Evelyn Chan, MD, MS University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research
  More Information

Responsible Party: Jessica A. Calderon-Mora, University of Texas Health Science Center
ClinicalTrials.gov Identifier: NCT00137618     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-2507
First Submitted: August 26, 2005
First Posted: August 30, 2005
Last Update Posted: March 18, 2010
Last Verified: March 2010

Keywords provided by Centers for Disease Control and Prevention:
Prostatic neoplasm
Prostate cancer
Informed decision making
Prostate cancer screening
Prostate specific antigen

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases