Does the label given to a low-risk prostate lesion influence patient management choice?
Not Applicable
- Conditions
- Prostate cancerPublic Health - Other public healthCancer - ProstateMental Health - Studies of normal psychology, cognitive function and behaviour
- Registration Number
- ACTRN12624000212550
- Lead Sponsor
- The University of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1290
Inclusion Criteria
To be included in the trial, participants must:
- Have a prostate.
- Be 50 years or older.
- Understand written English.
- Be living in Australia.
Exclusion Criteria
Participant has a prior history of prostate cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Choice of management option.[Outcome is a binary choice between (1) monitoring (PSA monitoring or active surveillance) versus (2) immediate treatment (radical prostatectomy or radiotherapy). Immediately after intervention.]
- Secondary Outcome Measures
Name Time Method Diagnosis anxiety.[11-point single-question Visual Analogue Scale, with anchored end points of 0 = not anxious at all and 10 = extremely anxious. Immediately after intervention.];Treatment choice anxiety.[11-point single-question Visual Analogue Scale, with anchored end points of 0 = not anxious at all and 10 = extremely anxious. Immediately after intervention.];Management choice at a later time point (for those initially choosing PSA monitoring or active surveillance).[Direct choice between two management options: continue monitoring versus immediate treatment. Immediately after intervention.];Explanation of management choice[Free-text input. Immediately after intervention.];Management choice from four options[Direct choice between 4 specified management options: PSA monitoring, active surveillance, prostatectomy, radiotherapy Immediately after intervention]