Informed Decision-Making Regarding Prostate Specific Anti... | NCT00761124

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

NCT00761124

Sponsor

Jonsson Comprehensive Cancer Center

Status

Active, not recruiting

Last Update Posted

Mar 7, 2025Actual

Enrollment

1,006Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Intervention Session
Printed Material

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01CA102486	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003Actual

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Sep 26, 2008

First Submission Date that Met QC Criteria

Sep 26, 2008

First Posted Date

Sep 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2025

Last Update Posted Date

Mar 7, 2025Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,006Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Educational small group session regarding prostate cancer	Behavioral: Intervention Session
2	Other	Printed material regarding general prostate cancer information provided.	Behavioral: Printed Material

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intervention Session	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inform Decision-Making		6 months post-baseline interview

Secondary Outcomes

Measure	Description	Time Frame
Prostate cancer knowledge, Receipt of PSA, and Communication with family, friends, and medical providers		6 months post-baseline interview

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roshan Bastani, PhD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA, Division of Cancer Prevention and Control Research		Los Angeles	California	90095	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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