Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening (PSAMG)
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|ClinicalTrials.gov Identifier: NCT02156869|
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : June 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Decision aid||Not Applicable|
A Cochrane systematic review of 5 randomized controlled trials showed that screening for prostate cancer, using digital rectal examination and dosage of prostate specific antigen (PSA), did not significantly decrease prostate cancer specific mortality. Rather, screening for prostate cancer often led to over-diagnosis by detecting tumors that would not otherwise have become symptomatic or by producing false positive results. It could therefore result in unnecessary supplementary testing (including prostate biopsies), inadequate and/or harmful treatment, and negative psychological outcomes among patients.
Although the growing number of recommendations against PSA testing for screening of prostate cancer, 70% of patients still request testing prior to any information because they overestimate the benefits and are unaware of the limitations. As a result, about 55% of patients between 50 and 74 years old, undergo prostate cancer screening in the USA every year, despite recommendations against it.
To help patients understand the complexities about PSA testing for prostate cancer screening, professional organizations encourage physicians and patients to use decision aids to make informed decisions.
The aim of this study was to evaluate the impact of a decision aid, usable in daily practice by general practitioners, presenting harms and benefits of prostate cancer screening on patients' intent to undergo screening.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening: a Multicenter Pragmatic Randomized Controlled Trial|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||June 2014|
Experimental: Intervention arm
The intervention was the use of a decision aid.
Other: Decision aid
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.
No Intervention: Control arm
- patients' intent to undergo screening for prostate cancer [ Time Frame: Immediate ]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.
- Reasons to undergo or not screening for prostate cancer [ Time Frame: Immediate ]We systematically asked patients to elicit reasons underlying their answers using open-ended questions. Answers were read by a single investigator (EKR) and classified into categories. We compared proportion of individuals eliciting ech reason between the 2 arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156869
|Paris, France, 75000|
|Principal Investigator:||Viet Thi Tran, MD||Paris Diderot University|