Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments intervention session, printed material
Phase phase 2
Sponsor Jonsson Comprehensive Cancer Center
Collaborator National Institutes of Health (NIH)
Start date April 2003
End date April 2017
Trial size 1006 participants
Trial identifier NCT00761124, R01CA102486

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
Educational small group session regarding prostate cancer
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)
Printed material regarding general prostate cancer information provided.
printed material
General prostate cancer pamphlet

Primary Outcomes

Measure
Inform Decision-Making
time frame: 6 months post-baseline interview

Secondary Outcomes

Measure
Prostate cancer knowledge, Receipt of PSA, and Communication with family, friends, and medical providers
time frame: 6 months post-baseline interview

Eligibility Criteria

Male participants from 50 years up to 70 years old.

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

Additional Information

Official title Informed Decision-Making Regarding PSA Screening
Principal investigator Roshan Bastani, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center.