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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 26, 2005 | ||||||||
| Last Updated Date | December 12, 2005 | ||||||||
| Start Date ICMJE | November 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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 | ||||||||
| Original Primary Outcome Measures ICMJE |
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 followin | ||||||||
| Change History | Complete list of historical versions of study NCT00137618 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening | ||||||||
| Official Title ICMJE | Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Univ of Texas - SIP 21-04 | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment | ||||||||
| Condition ICMJE | Prostate Cancer | ||||||||
| Intervention ICMJE | Behavioral: Educational Intervention to Increase Informed Decision Making for Prostate Cancer Screening | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 264 | ||||||||
| Completion Date | October 2006 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 40 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00137618 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDC-NCCDPHP-2507 | ||||||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||||||
| Collaborators ICMJE | The University of Texas Health Science Center, Houston | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||||||
| Verification Date | August 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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