Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000213549
Ethics application status
Approved
Date submitted
16/11/2023
Date registered
4/03/2024
Date last updated
4/03/2024
Date data sharing statement initially provided
4/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the label given to a low-risk prostate lesion influence management choice in patient partners?
Scientific title
Effect of the diagnostic label for a low-risk prostate lesion on preferred management strategy for patient partners: a randomised experiment
Secondary ID [1] 310973 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 332059 0
Condition category
Condition code
Public Health 328784 328784 0 0
Other public health
Cancer 328785 328785 0 0
Prostate
Mental Health 328786 328786 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327405 0
Behaviour
Comparator / control treatment
The control group will be randomised to receive the diagnostic label of prostate cancer, grade group 1 (current standard of care).
Control group
Active

Outcomes
Primary outcome [1] 336594 0
Choice of management option.
Timepoint [1] 336594 0
Immediately after intervention.
Secondary outcome [1] 428904 0
Diagnosis anxiety.
Timepoint [1] 428904 0
Immediately after intervention.
Secondary outcome [2] 428905 0
Treatment choice anxiety.
Timepoint [2] 428905 0
Immediately after intervention.
Secondary outcome [3] 428906 0
Management choice at a later time point (for those initially choosing PSA monitoring or active surveillance)
Timepoint [3] 428906 0
Immediately after intervention.
Secondary outcome [4] 428908 0
Explanation of management choice.
Timepoint [4] 428908 0
Immediately after intervention.
Secondary outcome [5] 432306 0
Management choice from four options
Timepoint [5] 432306 0
Immediately after intervention

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer using Qualtrics survey software. Researchers will have no direct contact with participants. Once a participant agrees to take part in the study they will be randomly assigned to be immediately sent a questionnaire containing one of the hypothetical scenarios.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics computer software will randomly allocate each participant to one of the arms of the trial as they enter the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All analyses will adhere to the intention-to-treat principle, with participant data analysed according to the randomly assigned study arm, regardless of adherence to the study protocol. We will present categorical data using counts and percentages, and continuous data using the minimum and maximum, mean, and standard deviation (SD) or median and quartile 1 (Q1) and quartile 3 (Q3). For each outcome, we will present the number of participant responses included in the analysis.

Statistical analyses will use a superiority framework to make pairwise comparisons across the three label groups. We will use logistic regression for binary outcomes and linear regression for continuous outcomes. We will present 95% confidence intervals (CI) for effect estimates on all primary and secondary outcomes. Effect modification of the label effects by provision of comprehensive information will be explored through testing significance of interaction terms with the label group variable. All hypothesis tests will be two-sided with an a of 5%. P-values from secondary analyses will not be adjusted for multiple testing and so will be interpreted conservatively.

We will estimate unadjusted and adjusted effects using the relevant regression model. For the adjusted analyses, we will include baseline measurements of important prognostic factors for the outcome in the model, which is recommended to improve the power of the study and to obtain valid standard errors when using stratification. These will include variables used in sampling strata: age, education, geographic location (by state/territory) and rurality (urban vs regional vs rural). Other prognostic factors will be measured through the baseline questionnaire, and include baseline anxiety levels, prior diagnosis of (non-prostate) cancer, diagnosis of prostate cancer in a family member or close friend. The effects of participants’ health literacy on intervention effects will also be explored as a potential confounder.

Data analysis will be conducted in R / RStudio.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
1410
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315969 0
Government body
Name [1] 315969 0
NHMRC
Country [1] 315969 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
School of Public Health, Edward Ford Building A27, The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 318111 0
None
Name [1] 318111 0
Address [1] 318111 0
Country [1] 318111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314156 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314156 0
Ethics committee country [1] 314156 0
Australia
Date submitted for ethics approval [1] 314156 0
26/07/2023
Approval date [1] 314156 0
21/09/2023
Ethics approval number [1] 314156 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130614 0
Prof Katy Bell
Address 130614 0
Rm 101 Edward Ford Building A27, The University of Sydney, Gadigal Country, NSW 2006
Country 130614 0
Australia
Phone 130614 0
+61293514823
Fax 130614 0
Email 130614 0
katy.bell@sydney.edu.au
Contact person for public queries
Name 130615 0
Katy Bell
Address 130615 0
Rm 101 Edward Ford Building A27, The University of Sydney, Gadigal Country, NSW 2006
Country 130615 0
Australia
Phone 130615 0
+61293514823
Fax 130615 0
Email 130615 0
katy.bell@sydney.edu.au
Contact person for scientific queries
Name 130616 0
Katy Bell
Address 130616 0
Rm 101 Edward Ford Building A27, The University of Sydney, Gadigal Country, NSW 2006
Country 130616 0
Australia
Phone 130616 0
+61293514823
Fax 130616 0
Email 130616 0
katy.bell@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified questionnaire response data.
When will data be available (start and end dates)?
01/09/2024 ongoing.
Available to whom?
Researchers on reasonable request.
Available for what types of analyses?
Quantitative and qualitative research analyses relating to prostate cancer diagnosis.
How or where can data be obtained?
Contact primary investigator: katy.bell@sydney.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.