NCT02156869

Brief Summary

Although the number of recommendations against systematic screening of prostate cancer, 70% of patients still request testing because they overestimate the benefits and are unaware of the limitations. The investigators aim is to assess the impact of a short printed decision aid presenting benefits and limits of screening, on patients' intent to undergo prostate cancer screening.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,170

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

June 3, 2014

Last Update Submit

June 4, 2014

Conditions

Prostate Cancer

Keywords

Prostate cancerScreeningDecision aids

Outcome Measures

Primary Outcomes (1)

  • patients' intent to undergo screening for prostate cancer

    patients' intent to undergo screening for prostate cancer was assessed by the question: "Do you want to be screened (or in case you have already been screened before, do intend to continue to be screened) for prostate cancer?" in a self administered questionnaire. Patients could answer "Yes", "No" or "I don't know", measured one time after receiving the decision aid or not.

    Immediate

Other Outcomes (1)

  • Reasons to undergo or not screening for prostate cancer

    Immediate

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention was the use of a decision aid.

Other: Decision aid

Control arm

NO INTERVENTION

Usual care

Interventions

Decision aidOTHER

Intervention was use of a decision aid. Decision aid contained information about: 1) the epidemiology of prostate cancer; 2) what is a PSA test and advantages and limits of screening for prostate cancer using it (including risk of overtreatment and risk of becoming impotent and/or incontinent) and; 3) the position on screening for prostate cancer of major scientific societies in France at the time of the study. The second page contained a visual representation of the benefits of PSA screening for prostate cancer versus usual care based on the results of the European Randomized study of Screening for Prostate Cancer trial (ERSPC) The decision aid was pretested with 20 patients to ensure clarity and wording. It was revised accordingly to comments.

Intervention arm

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male patients from 50 to 75 years old

You may not qualify if:

  • personal history of prostate cancer
  • any urinary tract symptoms
  • history of prostate cancer in a first degree relative
  • known exposition to chlordecone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SFTG

Paris, 75000, France

Location

Related Publications (2)

  • Moyer VA; U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Jul 17;157(2):120-34. doi: 10.7326/0003-4819-157-2-201207170-00459.

    PMID: 22801674BACKGROUND

  • Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.

    PMID: 24470076BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Viet Thi Tran, MD

    Paris Diderot University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 5, 2014

Study Start

November 1, 2012

Primary Completion

February 1, 2013

Study Completion

June 1, 2014

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations

FR(1)