None listed
Conditions
Brief summary
This study aims to explore whether an alternative label used to communicate a hypothetical low-risk prostate cancer diagnosis influences management choice and level of anxiety among men in Australia. Who is it for? You may be eligible for this study if you are an adult with a prostate who does not have a history of prostate cancer. Study details Participants will be randomly assigned randomised to receive one of three hypothetical scenarios about the diagnosis of a low-risk prostate cancer received by themselves. Each group will be presented with a different diagnostic label. Within each scenario arm, participants will be further randomised to receive either limited information about their diagnosis and management options, or comprehensive information about their diagnosis. We will then survey participants about their preferred choice of management for that diagnosis, their level of anxiety about that diagnosis and their level of anxiety about that management choice. It is hoped that this study will help provide additional understanding on whether labels and provision of risk information will modify any effects of labels used for prostate cancer diagnosis.
Interventions
In this study, participants will be randomised to receive one of three hypothetical scenarios about the diagnosis of a low-risk prostate cancer. They will be presented with a different diagnostic label, and we will survey participants (using an online questionnaire) about their preferred choice of management for that diagnosis, their level of anxiety about that diagnosis and their level of anxiety about that management choice. The possible diagnostic labels are: 1. Prostate cancer, grade group 1 (control label). 2. Low-risk prostate lesion (intervention label 1). 3. Low-risk prostate neoplasm (intervention label 2). Within each scenario arm, participants will be further randomised to receive either limited information about their diagnosis and management options (the diagnostic label, and a short description of each of the three management options available), or comprehensive information about their diagnosis and management options (the same as in the limited information arm, except additional information is provided about the management options and the different absolute risk profiles associated with each one). This information is delivered on a computer screen as text and diagrams, contained within the online questionnaire. Participants have an unlimited amount of time to read and consider the information. There are no strategies used to ensure participants adhere to the provided arm (i.e. we do not monitor if they read the text or for how long). This study is a between-subjects factorial (3 x 2) randomised online experiment. Following consent, eligible participants will be randomised 1:1 to receive the control label, intervention label 1 or intervention label 2. Participants will then undergo a second randomisation step with 1:1 allocation into provision of detailed absolute risk information vs no provision of absolute risk information. The primary outcome and secondary outcomes will be compared across randomised groups.
Sponsors
Study design
Eligibility
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.