None listed
Conditions
Brief summary
This study aims to investigate whether using alternative diagnosis labels for melanoma in situ has any impact on worry/anxiety and treatment preferences for adults. Who is it for? You may be eligible for this study if you are aged 40 years or older and are in good general health without a clinically significant medical history. People who have been diagnosed with melanoma will not be eligible for this study. Study details This trial will be conducted online and no in-person visits are required. Participants who choose to enrol in this study will be asked to access an online survey via a link provided to them by email. Participants will then be presented with one of three different diagnosis scenarios where one of three labels for low-risk melanoma may be used. After reviewing this information, participants will then be asked to respond to a series of questions 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. Completion of the survey is anticipated to take up to 15 minutes during a single session, no further participation is required. It is hoped this research will determine whether different diagnosis labels influence management choices and anxiety after a low-risk melanoma diagnosis.
Interventions
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 si
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.
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
40 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
Has a prior history of melanoma (invasive or in-situ).
Outcome results
None listed