Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000043932
Ethics application status
Approved
Date submitted
17/12/2019
Date registered
21/01/2020
Date last updated
31/01/2023
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation into the psychosocial and behavioural impact of genetic testing for familial melanoma
Scientific title
Investigation into the psychosocial and behavioural impact of genetic testing for familial melanoma
Secondary ID [1] 300117 0
AML001
Universal Trial Number (UTN)
U1111-1245-5840
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Familial Melanoma 315650 0
Psychosocial Wellbeing 315806 0
Condition category
Condition code
Human Genetics and Inherited Disorders 313939 313939 0 0
Other human genetics and inherited disorders
Cancer 314097 314097 0 0
Malignant melanoma
Mental Health 314098 314098 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is receiving pre- and post-test genetic consultation for Familial Melanoma, from a clinician who has been trained in this study to provide genetic testing.

Before genetic testing is requested, study participants will attend a pre-testing genetic education and counselling session led by either a genetic counsellor (control group), or a dermatologist trained clinician who has been trained by a genetic counsellor (intervention group). During this session participants can ask any questions and will receive education on genetics, the likelihood of detecting a mutation (based on medical/family history), and the possible impact on family members. At the end of this session, participants will decide if they wish to go ahead with genetic testing. For consenting participants, a saliva sample will be collected using a DNA self-collection kit (at the end of the first visit). This sample is sent to an accredited genetic testing laboratory in the USA (Invitae) for panel testing of known genes associated with melanoma risk.

Genetic test results will be reported back to participants during a second (face-to-face) appointment with the genetic counsellor (control group) or clinician trained by a genetic counsellor (intervention). This will be scheduled between 1-3 months after the first visit, depending on when results are available and the availability of staff and participants. This session will include; reporting of results, explanation of significance for personal risk, significance for family risk, recommended preventative health behaviour and screening, and to answer any participant questions.

Intervention code [1] 316391 0
Prevention
Intervention code [2] 316518 0
Early detection / Screening
Comparator / control treatment
control group - those receiving their genetic consultation by a certified genetic councellor (standard of care for genetic testing).
Control group
Active

Outcomes
Primary outcome [1] 322329 0
The primary outcome will be patient satisfaction with the genetic testing process, measured using the GCSS (Genetic Counselling Satisfaction Scale) (DeMarco et al, 2004).
Timepoint [1] 322329 0
2 weeks after genetic test results are received
Secondary outcome [1] 378137 0
Pyschosocial Impact of genetic testing, using validated survey instruments and analysed quantitatively.

specific questionnaires used:
- HADS (Hospital Anxiety and Depression Scale) (Zigmond & Snaith 1983)
- Cancer Worry Scale (Custers et al 2014)
- Fatalism Scale (Shen et al 2009)
- Belief in genetic determinism (Carver et al 2017)
- MICRA (Multidimensional Impact of Cancer Risk Assessment) (Cella et al 2002)
- Genomics outcomes scale (Grant et al 2019)
- Genetic Counselling Satisfaction Scale (GCSS) (DeMarco 2004)
- Perceived personal control scale (Berkenstadt et al 1999)
- Decision regret scale (Brehaut et al 2003)
- Decision satisfaction (Holmes-Rovner et al 1996)
- Percieved benefits and limitations of genetic testing (Kasparian et al 2009)
- Multidimensional Health Locus of Control (MHLC) (Wallston et al 1978)
- Health Belief Model (HBM) (Becker & Maiman 1975)
Timepoint [1] 378137 0
1 week, 3 months, 12 months, post genetic test results reported.
Secondary outcome [2] 378138 0
health behaviour change, using self reported information in questionnaires (questionnaire not previously validated, it is specific to this study).

For example; questions on sun exposure and sun protective behaviour (e.g. use of sunscreen, avoiding sun at peak times etc.). Also questions on whether participants have conducted self-skin examinations and attended any clinical skin examinations.
Timepoint [2] 378138 0
3 months and 12 months post genetic test results reported - and compared to baseline self-reported health behaviour.
Secondary outcome [3] 417942 0
to understand and describe the participant’s experience with living with familial melanoma, and the genetic testing process, with a particular focus on fatalistic beliefs. This will be achieved by conducting semi-structure interviews with participants, one month after they received their genetic test results. Interviews will be conducted over the phone and should take between 30-60 minutes. The interviews are recorded, and transcribed verbatim. Interview transcripts are then qualitatively analysed using thematic analysis, a process widely used to generate knowledge on the lived experiences of study participants.
Timepoint [3] 417942 0
1 month after test results are disclosed
Secondary outcome [4] 417943 0
Using qualitative methods, interviews will be conducted with clinicians who participated in a training program to provide genetic testing for familial melanoma. Interviews will use a semi-structured guide and will be conducted one-on-one either in person or over the phone. The interviews will cover two topics regarding the training process and clinician's perceptions on the utility of genetic testing for familial melanoma.
The objective of the interviews is to receive constructive feedback to guide a future training initiative for clinical implementation.
Timepoint [4] 417943 0
After clinicians have completed the training program and have independantly provided genetic testing consultation for familial melanoma within the study.

Eligibility
Key inclusion criteria
- 3 primary melanomas in an individual, and/or
- families with 1 or more invasive melanoma AND 2 or more other invasive melanomas and/or pancreatic cancer among first-degree or second-degree relatives on the same side of the family
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is the survey response to the GCSS (Genetic Counselling Satisfaction Scale) at timepoint 3 (2 weeks after test results are disclosed). Secondary outcomes include patient’s long-term psychological impact of genetic testing, as well as any impact on personal empowerment and engaging in protective behaviours, as captured using previously validated scales. These are scored and interpreted using methods as originally described by authors of the scales. Descriptive statistics are used to summarise participant characteristics. Bivariate analyses conducted examine clinically relevant differences in outcomes between groups, using crosstabulations and chi squared tests for categorical variables and t-tests for continuous variables. Specifically, differences in mean GCSS scores between the two participant groups (trained clinician versus genetic counsellor) are compared using an unpaired t-test, with a p value <0.05 considered statistically significant. Logistic regression is used to identify predictor psychosocial variables for GCSS. Analysis of secondary outcomes is driven by the study aims and hypotheses to address whether participant reported outcomes and preventative behaviours differ depending on provider type for genetic testing consultation. Patterns of missing data are examined, and where any variable has more than 10% missing data, a ‘missing’ category is defined and included in analyses, to maximise the use of available data.
Thematic analysis is used for qualitative analysis of interview transcripts, utilising NVivo Software to manage transcripts and the coding process. Thematic analysis is a widely used methodology to generate a description of key themes raised by interviewees and involves six core steps. The methodology for analysis follows methods described by Clark & Braun (2006), and includes 1) familiarisation with transcripts, 2) Assigning codes to relevant or interesting text, 3) Recognise overarching themes that apply to connecting codes, 4) Review the themes and adjust coding where suitable, 5) Name and describe each theme, and 6) Generate a report for publication in the context of the research questions and current literature.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2020
Actual
1/03/2020
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
100
Accrual to date
76
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15526 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28890 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304558 0
University
Name [1] 304558 0
The University of Queensland
Country [1] 304558 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 304839 0
None
Name [1] 304839 0
None
Address [1] 304839 0
n/a
Country [1] 304839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304984 0
Metro South Health
Ethics committee address [1] 304984 0
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 304984 0
Australia
Date submitted for ethics approval [1] 304984 0
17/10/2019
Approval date [1] 304984 0
12/11/2019
Ethics approval number [1] 304984 0
HREC/2019/QMS/58196

Summary
Brief summary
Brief description of the study purpose
The study aims to Investigate the psychosocial and behavioural impact of genetic testing for familial melanoma. It also evaluates a training program for clinicians to provide genetic testing for familial melanoma, based on participant satisfaction.

Who is it for?
You may be eligible for this study if you are 18 years or older, with 3 primary melanomas and/or a family member with 1 or more invasive melanomas and 2 or more other invasive melanomas and/or pancreatic cancer among first-degree or second-degree relatives on the same side of the family.

Study details
Participation in the study will involve a pre-testing genetic counselling and education visit. You will be seen by either a genetic counsellor (standard practice of care), or by a clinician who has received training to provide genetic testing (the 'intervention group'). Participants will then have their saliva collected for genetic testing, and will attend a second visit to receive their test results. At both visits, participants will be asked to complete questionnaires (approx 30 mins). One month after receiving their genetic test results, participants will asked to complete a phone interview where questions about their experience in the study will be discussed. Participants will also be required to answer questionnaires about the psychological impact of genetic testing and regarding their sun protective behaviour after results have been received. A link to the questionnaires will be emailed to participants at 1 week, 3 months and 12 months after receiving their results, and can be completed online.

It is hoped this study will provide greater insight into the role of genetic testing and the impact on mental health, and sun protective behaviour.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98862 0
Dr Aideen McInerney-Leo
Address 98862 0
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country 98862 0
Australia
Phone 98862 0
+61 7 3443 7057
Fax 98862 0
Email 98862 0
[email protected]
Contact person for public queries
Name 98863 0
Clare Primiero
Address 98863 0
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country 98863 0
Australia
Phone 98863 0
+61 7 3443 7496
Fax 98863 0
Email 98863 0
[email protected]
Contact person for scientific queries
Name 98864 0
Clare Primiero
Address 98864 0
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country 98864 0
Australia
Phone 98864 0
+61 7 3443 7496
Fax 98864 0
Email 98864 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
For now we are unsure what IPD we will produce that may be useful and able to share. We will update this at a later time.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18188Study protocolPrimiero CA, Finnane A, Yanes T, Peach B, Soyer HP, et al. (2022) Protocol to evaluate a pilot program to upskill clinicians in providing genetic testing for familial melanoma. PLOS ONE 17(12): e0275926. https://doi.org/10.1371/journal.pone.0275926https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0275926 



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.