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

Prostate Cancer Clinical Trial

Official title:

Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Univ of Texas - SIP 21-04

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137618
• Other study ID #: CDC-NCCDPHP-2507
• Status: Completed
• Phase: N/A
• First received: August 26, 2005
• Last updated: March 16, 2010
• Start date: November 2004
• Est. completion date: September 2008

Study information

• Verified date: March 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of South Carolina, Arnold School of Public Health	Columbia	South Carolina
United States	UT Houston School of Public Health, El Paso Regional Campus	El Paso	Texas
United States	University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.