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 partners of those with prostates. Who is it for? You may be eligible for this study if you are the partner of 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 their partner. 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 partner's diagnosis and management options, or comprehensive information. We will then survey participants about their preferred choice of management for their partner's 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 a low-risk 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 lesion in their partner. We will survey participants (using an online questionnaire) about their preferred choice of management for that diagnosis of their partner, their level of anxiety about the 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-ri
In this study, participants will be randomised to receive one of three hypothetical scenarios about the diagnosis of a low-risk prostate lesion in their partner. We will survey participants (using an online questionnaire) about their preferred choice of management for that diagnosis of their partner, their level of anxiety about the 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. Indolent lesion of epithelial origin (intervention label 2). Within each scenario arm, participants will be further randomised to receive either limited information about the diagnosis of their partner and management options (the diagnostic label, and a short description of each of the three management options available), or comprehensive information about the diagnosis of their partner 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
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be included in the trial, participants must: - Not have a prostate. - Be 30 years or older. - Understand written English. - Be living in Australia.
Exclusion criteria
Participant does not have a partner aged 50 years or more who has a prostate. Participant's partner has a prior history of prostate cancer.
Outcome results
None listed