Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000740594
Ethics application status
Approved
Date submitted
5/12/2023
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the label given to low-risk melanoma influence patient management choice?
Scientific title
Effect of the label for a low-risk melanocytic lesion on preferred management strategy in Australian adults: an online randomised study
Secondary ID [1] 311039 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 332152 0
Fear of cancer 332153 0
Condition category
Condition code
Cancer 328873 328873 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, participants will be randomised 1:1:1 to receive one of three hypothetical scenarios about the diagnosis of a low-risk melanocytic skin lesion. They will be presented with a different diagnostic label, and we will survey participants (using an online questionnaire) about their preferred choices 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. melanoma in situ 1 (control label).
2. low-risk melanocytic neoplasm (intervention label 1).
3. low-risk melanocytic neoplasm, in situ (intervention label 2).

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).

The primary outcome and secondary outcomes will be compared across randomised groups.
Intervention code [1] 327481 0
Diagnosis / Prognosis
Intervention code [2] 328824 0
Behaviour
Comparator / control treatment
The control group will be randomised to receive the diagnostic label of melanoma in-situ (current standard of care).
Control group
Active

Outcomes
Primary outcome [1] 336678 0
Choice of further surgery:
• No further surgery
• Further surgery to ensure clear margins >0.5mm
Timepoint [1] 336678 0
Immediately after intervention.
Primary outcome [2] 336679 0
Choice of follow-up:
• Patient-led surveillance: self-monitoring with patient-initiated clinic visits as needed.
• Clinician-led surveillance: six monthly routinely scheduled clinic visits (current standard care after diagnosis of melanoma in situ).
Timepoint [2] 336679 0
Immediately after intervention.
Secondary outcome [1] 429307 0
Diagnosis of anxiety
Timepoint [1] 429307 0
Immediately after intervention.
Secondary outcome [2] 429308 0
Treatment choice anxiety
Timepoint [2] 429308 0
Immediately after intervention.
Secondary outcome [3] 429311 0
Rationale for Decisions
Timepoint [3] 429311 0
Immediately after intervention.
Secondary outcome [4] 435951 0
perceived lifetime risk of invasive melanoma
Timepoint [4] 435951 0
Immediately after intervention
Secondary outcome [5] 435952 0
perceived risk of dying from melanoma
Timepoint [5] 435952 0
Immediately after intervention

Eligibility
Key inclusion criteria
To be included in the trial, participants will be eligible if they are:
• 40 years or older.
• Understand written English.
• Reside in Australia.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Has a prior history of melanoma (invasive or in-situ).

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
The analysis will focus on assessing the impact of different diagnostic labels for melanoma in situ on participants' psychological responses and healthcare decisions. Data analysts will be blinded to intervention assignment. For both co-primary outcomes, we will compare the proportion chosen for each management option. For first four secondary outcomes, we will compare summary statistical measures (means or medians) across randomised groups. For the last outcome, we will use thematic framework methods of qualitative data.

The analysis will adhere to the intention-to-treat principle, and participant data will be analyzed according to their randomly assigned diagnostic label group, regardless of adherence to the study protocol. The number of participant responses included in each analysis will be presented for each outcome. We will summarize categorical data for the randomised groups using counts and percentages, and continuous data using the minimum and maximum, mean, and standard deviation (SD) or median and interquartile range (IQR).

Statistical analyses will be conducted within a superiority framework to make pairwise comparisons across the three diagnostic label groups. Binary outcomes will be analyzed using logistic regression. Continuous outcomes will be analyzed using linear regression. For the cancer worry outcome, we will compare changes in worry across randomised groups by including baseline scores as a covariate in the regression model. Effect estimates for all primary and secondary outcomes will be presented with associated 95% confidence intervals (CI). All hypothesis tests will be two-sided with a significance level (a) of 5%. The potential for participants' health literacy to act as an effect modifier of intervention effects will be explored.

We will estimate unadjusted and adjusted effects using the relevant regression model. These will include variables used in sampling strata: age, education, geographic location (by state/territory). Prognostic factors will be measured through the baseline questionnaire, and include baseline anxiety levels, sun exposure behavior, prior diagnosis of melanoma, diagnosis of melanoma in a family member. 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
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1688
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315296 0
Government body
Name [1] 315296 0
National Health and Medical Research Council
Country [1] 315296 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] 317341 0
None
Name [1] 317341 0
Address [1] 317341 0
Country [1] 317341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314220 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314220 0
Ethics committee country [1] 314220 0
Australia
Date submitted for ethics approval [1] 314220 0
02/11/2023
Approval date [1] 314220 0
06/05/2024
Ethics approval number [1] 314220 0
2024/HE000019

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

Contacts
Principal investigator
Name 130830 0
A/Prof Katy Bell
Address 130830 0
A27 - Edward Ford Building The University of Sydney NSW 2006 Australia
Country 130830 0
Australia
Phone 130830 0
+61 2 9351 4823
Fax 130830 0
Email 130830 0
[email protected]
Contact person for public queries
Name 130831 0
Katy Bell
Address 130831 0
A27 - Edward Ford Building The University of Sydney NSW 2006 Australia
Country 130831 0
Australia
Phone 130831 0
+61 2 9351 4823
Fax 130831 0
Email 130831 0
[email protected]
Contact person for scientific queries
Name 130832 0
Katy Bell
Address 130832 0
A27 - Edward Ford Building The University of Sydney NSW 2006 Australia
Country 130832 0
Australia
Phone 130832 0
+61 2 9351 4823
Fax 130832 0
Email 130832 0
[email protected]

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 and ongoing
Available to whom?
Researchers on reasonable request.
Available for what types of analyses?
Quantitative and qualitative research analyses relating to melanoma in situ diagnosis.
How or where can data be obtained?
Contact primary investigator: [email protected]


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.