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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Session
Printed Material
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring PSA screening, Prostate cancer and Latino men

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA, Division of Cancer Prevention and Control Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Educational small group session regarding prostate cancer

Printed material regarding general prostate cancer information provided.

Outcomes

Primary Outcome Measures

Inform Decision-Making

Secondary Outcome Measures

Prostate cancer knowledge, Receipt of PSA, and Communication with family, friends, and medical providers

Full Information

First Posted
September 26, 2008
Last Updated
March 14, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00761124
Brief Title
Informed Decision-Making Regarding Prostate Specific Antigen (PSA) Screening in 50-70 Year Old Latino Men
Acronym
PSA
Official Title
Informed Decision-Making Regarding PSA Screening
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2003 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PSA screening, Prostate cancer and Latino men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1006 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Educational small group session regarding prostate cancer
Arm Title
2
Arm Type
Other
Arm Description
Printed material regarding general prostate cancer information provided.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Session
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Printed Material
Intervention Description
General prostate cancer pamphlet
Primary Outcome Measure Information:
Title
Inform Decision-Making
Time Frame
6 months post-baseline interview
Secondary Outcome Measure Information:
Title
Prostate cancer knowledge, Receipt of PSA, and Communication with family, friends, and medical providers
Time Frame
6 months post-baseline interview

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshan Bastani, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA, Division of Cancer Prevention and Control Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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