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

• ClinicalTrials.gov Identifier: NCT00137618
• Recruitment Status: Completed
• First Posted: August 30, 2005
• Last Update Posted: March 18, 2010
• Sponsor: Centers for Disease Control and Prevention
• Collaborator: The University of Texas Health Science Center, Houston
• Information provided by: Centers for Disease Control and Prevention

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Behavioral: Educational Intervention to Increase Informed Decision Making for Prostate Cancer Screening	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 264 participants
• 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
• Study Start Date: November 2004
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: CDC-NCCDPHP-2507
• 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; Prostatic Diseases