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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00761124
Collaborator
National Cancer Institute (NCI) (NIH)
1,006
1
2
250.1
4

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Intervention Session
  • Behavioral: Printed Material
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1006 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Informed Decision-Making Regarding PSA Screening
Actual Study Start Date :
Apr 1, 2003
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Other: 2

Printed material regarding general prostate cancer information provided.

Behavioral: Printed Material
General prostate cancer pamphlet

Outcome Measures

Primary Outcome Measures

  1. Inform Decision-Making [6 months post-baseline interview]

Secondary Outcome Measures

  1. Prostate cancer knowledge, Receipt of PSA, and Communication with family, friends, and medical providers [6 months post-baseline interview]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 UCLA, Division of Cancer Prevention and Control Research Los Angeles California United States 90095

Sponsors and Collaborators

  • Jonsson Comprehensive Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Roshan Bastani, PhD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00761124
Other Study ID Numbers:
  • 10-001693
  • R01CA102486
First Posted:
Sep 29, 2008
Last Update Posted:
Jul 7, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Jonsson Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022