Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000707561
Ethics application status
Approved
Date submitted
23/04/2024
Date registered
5/06/2024
Date last updated
5/06/2024
Date data sharing statement initially provided
5/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protocol for a Randomised Controlled Trial to evaluate psychosocial and behaviour impact of providing personalised risk scores for melanoma
Scientific title
Protocol for a Randomised Controlled Trial to evaluate psychosocial and behaviour impact of providing personalised risk scores for melanoma in a high-risk, adult cohort.
Secondary ID [1] 312024 0
None
Universal Trial Number (UTN)
Trial acronym
PRiSMM
Linked study record
This is a sub-study of ACTRN12619001706167.

Health condition
Health condition(s) or problem(s) studied:
melanoma 333629 0
Condition category
Condition code
Cancer 330315 330315 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study recruited from a larger Australian cohort (a study registered under ACTRN12619001706167) and used a single-blind, longitudinal two-arm randomised controlled design to evaluate the value and impact of incorporating PRS information into melanoma risk assessments.

Participants were randomised to receive a ‘traditional’ melanoma risk score based on clinical and environmental risk factors (control group), or ‘personalised’ melanoma risk score based PRS, clinical, and environmental risk factors (intervention group). Participants received their melanoma risk scores in the form of an information booklet and were offered a follow-up appointment to discuss the results. Individuals in the control group were offered a personalised risk booklet after 12 months.

For the intervention group, personalised risk scores were calculated using PRS scores and traditional risk factors (nevus counts, hair colour, first-degree family history of melanoma, personal history of melanoma and keratinocyte (non-melanoma) skin cancer, previous sunbed use, age, sex and country/state of birth) previously identified as significant predictors of melanoma risk. The final personalised risk score were developed using established methodology to evaluate the incremental contribution of genetic risk factors (SNPs), together with the traditional clinical and lifestyle factors. Ten-year risk scores were calculated based on previously described methods (doi.org:10.1111/jdv.19279; doi.org:10.1111/bjd.18524; doi: 10.1016/j.jid.2018.05.023) and adjusted according to melanoma incidence rates by geographical location, age, and sex using the Australian Institute Health and Welfare statistics. A genetic counsellor created each of the booklets and was available to discuss the results, upon request.

A mixed methods approach assessed impacts of receiving traditional versus personalised melanoma risk scores. Questionnaires were administered at baseline, 1-month, and 12-months to capture psychosocial (i.e. perception of risk and control, empowerment, genetic testing specific distress, uncertainty and experience, and personal utility) and behavioural outcomes (i.e. communication with healthcare professionals, attitudes and confidence toward risk management, sun-protective behaviours, skin surveillance and accessing informational resources). Qualitative interviews will be conducted with control group participants who elect to receive their PRS information at 12-month follow-up, to explore if they perceived any additional value in receiving PRS information.

Adherence was not an issue for this study as participants received a single risk booklet after baseline surveys were completed. Additionally, the control cohort will receive a second booklet (PRS+traditional risk factors) at 12 months. This information is not available through other avenues so we do not need to worry about control arm participants pursuing the PRS information through another avenue.

Personalisation of the data is made possible as participants provided demographic and clinical information when they participated in the parent study (ACTRN12619001706167). At that time they also provided a saliva sample for genetic analysis. This group were invited to participate in this study in January and February of 2024 to evaluate the significance of receiving this information. Surveys were completed at baseline, one month following receipt of results and will be completed at 12 months following result disclosure. Qualitative interviews will also be completed after 12 months for the control group.
Intervention code [1] 328471 0
Prevention
Comparator / control treatment
The control arm received a ‘traditional’ melanoma risk score designed specifically for this study, based on clinical and environmental risk factors, which were provided as part of the parent study (ACTRN12619001706167). These include nevus counts, hair colour, first-degree family history of melanoma, personal history of melanoma and keratinocyte (non-melanoma) skin cancer, previous sunbed use, age, sex and country/state of birth).
Participants received their melanoma risk scores in the form of a custom designed information booklet and were offered a follow-up appointment (in person or online) to discuss the results with the leading genetic counsellor. Individuals in the control group will be offered a personalised risk booklet after 12 months.
Online questionnaires were administered at baseline, 1-month, and will be administered at 12-months to capture psychosocial (i.e. perception of risk and control, empowerment, genetic testing specific distress, uncertainty and experience, and personal utility) and behavioural outcomes (i.e. communication with healthcare professionals, attitudes and confidence toward risk management, sun-protective behaviours, skin surveillance and accessing informational resources). Qualitative interviews will be conducted with control group participants who elect to receive their PRS information at 12-month follow-up, to explore if they perceived any additional value in receiving PRS information.
There are no strategies needed to monitor adherence as there are no other available alternatives for participants.
The control group received a information booklet designed for this study, summarising their traditional risk score, that incorporated individual clinical and lifestyle factors relating to melanoma risk. The information booklet was eighteen pages long, and covered the following topics; traditional risk factors for melanoma, a traditional risk assessment, an explanation on how the risk score was calculated, information on impact for family, information and resources for how to manage risk, and who to contact for more information.
For individuals with no personal history of melanoma, risk scores were based on traditional risk factors (nevus counts, hair colour, first-degree family history of melanoma, personal history of keratinocyte (non-melanoma) skin cancer, previous sunbed use, age, sex and country/state of birth) previously identified as significant predictors of melanoma risk. These factors are included in both groups.
Control group
Active

Outcomes
Primary outcome [1] 338070 0
Personal utility of receiving personalised (PRS) vs traditional risk scores for melanoma using quantitative and qualitative outcomes. This a composite primary outcome.
Timepoint [1] 338070 0
One month post receipt of results
Secondary outcome [1] 434368 0
Psychosocial sequalae of result receipt as captured by the MICRA (Multidimensional impact of cancer risk assessment).
Timepoint [1] 434368 0
1 month and 1-year post receipt of results
Secondary outcome [2] 434369 0
Communication within the family and with healthcare providers
Timepoint [2] 434369 0
Comparing responses between both groups at 1 year post receipt of results
Secondary outcome [3] 434370 0
Adherence to sun protective behaviours
Timepoint [3] 434370 0
Behaviours (sun-safety is measured at baseline and 1 year)
Secondary outcome [4] 434371 0
Confidence in recommended self- and clinical-skin examination behaviour.
Timepoint [4] 434371 0
Baseline and follow up (1 month and 1 year post receipt of results)
Confidence and perceived capability are measured at baseline, and at follow up (1 month and 1 year post receipt of results).
Secondary outcome [5] 434666 0
Perceived melanoma risk
Timepoint [5] 434666 0
Baseline and follow up (1 month and 1 year post results).
Secondary outcome [6] 435566 0
Confidence with performing sun-safety.
Timepoint [6] 435566 0
Baseline and 1 year post results.
Secondary outcome [7] 435568 0
Perceived control over melanoma risk
Timepoint [7] 435568 0
Administered at baseline, 1 month and 1 year post results

Eligibility
Key inclusion criteria
This is a sub-study from a larger trial (ACTRN12619001706167). This study will recruit 360 individuals in a longitudinal two-arm randomised controlled, single-blind trial. Individuals are recruited from a cohort of previous and existing study participants within the Australian Centre of Excellence in Melanoma Imaging and Diagnosis (ACEMID) Study (ethical approval reference: HREC/2019/QMS/57206). The setting is at the Princess Alexandra Hospital located in Brisbane, Queensland, Australia. Participants in this study represented various risk levels (low, moderate, and high risk) and range from 18 years old and up. Any participant who has previously provided a saliva sample for genetic analysis, and consented to be contacted for future research are eligible to be recruited to the present study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If not already enrolled in parent (ACEMID) trial, individuals are not eligible to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Half of participants receive both traditional and genomic risk information from the outset and the control arm receive traditional risk information at baseline and, after 12 months, are offered both the traditional and genomics information.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Basic descriptive statistics will be used to describe the sample and uptake of the intervention and control groups. Perceived control of melanoma risk and perceived risk relative to others will be summarised in figures and compared over time (baseline vs 1- vs 12-months), for different risk levels using Chi-square analysis. Changes in perceived risk of future melanoma and empowerment (GOS) will be assessed both between risk levels and across time points using mixed linear modelling. Differences in genetic testing related distress, uncertainty, and positive experiences (MICRA) will be evaluated using paired t-test at 1- vs 12-months. Data from the Personal Utility Scale will be summarised using basic descriptive statistics and will be evaluated for differences between risk levels using unpaired t-tests. For all statistical analyses, significance will be inferred at p=0.05.
Qualitative analysis
Thematic analysis will be conducted using the grounded theory approach described by Braun and Clarke (2006). This iterative process involves systematically identifying, comparing, and coding themes within and across interviews and accounts for deviant cases. Patterns and relationships between the codes will be used to develop second-order categories. The qualitative analysis software NVivo 11 will be used throughout data analysis to organize data into semantic themes (codes) and latent themes (themes). Initial coding and re-coding will be conducted by the research team. Any discrepancies in coding and overarching themes will be discussed and consolidated by researchers.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
25/01/2024
Date of last participant enrolment
Anticipated
Actual
29/02/2024
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
360
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316373 0
University
Name [1] 316373 0
The University of Queensland
Country [1] 316373 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318556 0
None
Name [1] 318556 0
Address [1] 318556 0
Country [1] 318556 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315182 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 315182 0
Ethics committee country [1] 315182 0
Australia
Date submitted for ethics approval [1] 315182 0
16/03/2023
Approval date [1] 315182 0
05/05/2023
Ethics approval number [1] 315182 0
HREC/2023/QMS/95556
Ethics committee name [2] 315183 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 315183 0
Ethics committee country [2] 315183 0
Australia
Date submitted for ethics approval [2] 315183 0
11/05/2023
Approval date [2] 315183 0
15/05/2023
Ethics approval number [2] 315183 0
2023/HE000957

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

Contacts
Principal investigator
Name 133914 0
A/Prof Aideen McInerney-Leo
Address 133914 0
TRI Level 5, 37 Kent St., Woolloongabba, QLD 4102
Country 133914 0
Australia
Phone 133914 0
+61 7 3443 7057
Fax 133914 0
Email 133914 0
[email protected]
Contact person for public queries
Name 133915 0
Courtney Wallingford
Address 133915 0
Level 5, TRI Building, 37 Kent St. Woolloongabba, QLD 4102
Country 133915 0
Australia
Phone 133915 0
+61 7 3443 7920
Fax 133915 0
Email 133915 0
[email protected]
Contact person for scientific queries
Name 133916 0
Aideen McInerney-Leo
Address 133916 0
TRI Level 5, 37 Kent St., Woolloongabba, QLD 4102
Country 133916 0
Australia
Phone 133916 0
+61 7 3443 7057
Fax 133916 0
Email 133916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As genomic data is potentially reidentifiable, we will not be sharing participant data.


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.