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Informed Decision-Making Regarding Prostate Specific Antigen (PSA) Screening in 50-70 Year Old Latino Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of California, Los Angeles.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00761124
First received: September 26, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

The purpose of this intervention trial is aiming to increase inform decision- making in Latino men regarding prostate cancer screening.

The investigators propose to find out how much Latino men know about the benefits and risks of prostate cancer screening and what factors influence how they decide whether or not to have screening. The investigators are also interested in learning how providing education information, both verbally and in print, about the risks and benefits of prostate cancer screening affects men's interest and knowledge.

The intervention is an interactive multi-media presentation made up of a small group of 8-10 Latino men gathered to discuss about prostate cancer, screening methods, treatment, and the controversy within the medical community regarding PSA screening. A facilitator guides the 1-hour discussion and encourages participant interaction. The effect of this intervention was tested on 1000 Latino men within Los Angeles county.

Participants were recruited from 38 community venues (churches, community center, etc.). All participants were interviewed before being randomized to receive written (control group) or oral (intervention) prostate cancer education material. All of the participants will be followed up at 6-months via a telephone interview.

The investigators hypothesize that the intervention group will have an increase knowledge of prostate cancer, will have increase communication with family, friends, and medical provider, and will have an increase rate of PSA screening compared to the control group.


Condition Intervention Phase
Prostate Cancer
 Behavioral: Intervention Session
Behavioral: Printed Material
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Informed Decision-Making Regarding PSA Screening

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Inform Decision-Making [ Time Frame: 6 months post-baseline interview ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate cancer knowledge, Receipt of PSA, and Communication with family, friends, and medical providers [ Time Frame: 6 months post-baseline interview ] [ Designated as safety issue: No ]

Enrollment: 1006
Study Start Date: April 2003
Estimated Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Educational small group session regarding prostate cancer
 Behavioral: Intervention Session
A one-hour discussion group composed of 8-10 Latino men. The session includes an interactive, multimedia presentation led by a facilitator to guide participant interaction.
No Intervention: 2
Printed material regarding general prostate cancer information provided.
 Behavioral: Printed Material
General prostate cancer pamphlet

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Latino men
  • 50 to 70 years old
  • Not ever having prostate biopsy
  • Not ever having prostate cancer
  • Not having had a PSA test within the past 12 months
  • Not having BPH (prostate inflammation)
  • Not currently experiencing prostate problems such as pain or burning sensation during urination, blood in urine, and/or desire to urinate frequently

Exclusion Criteria:

  • Not Latino
  • Younger than 50 or older than 70 years old
  • Currently experiencing prostate problems such as pain or burning sensations while urinating, blood in urine, and/or desire to urinate frequently
  • Living outside of Los Angeles county
  • Having had a prostate biopsy
  • Having had prostate cancer previously
  • Having had a prostatectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761124

Locations
United States, California
UCLA, Division of Cancer Prevention and Control Research
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
Investigators
Principal Investigator: Roshan Bastani, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Roshan Bastani, PhD / Professor and Associate Dean of Research, University of California, Los Angeles - School of Public Health
ClinicalTrials.gov Identifier: NCT00761124     History of Changes
Other Study ID Numbers: R01CA102486
Study First Received: September 26, 2008
Last Updated: September 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
PSA screening
Prostate cancer and Latino men

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

ClinicalTrials.gov processed this record on May 23, 2013