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
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring PSA screening, Prostate cancer and Latino men
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
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
NCT ID
NCT00761124
First Posted
September 26, 2008
Last Updated
March 14, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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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