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Trial registered on ANZCTR
Registration number
ACTRN12609000344291
Ethics application status
Approved
Date submitted
4/05/2009
Date registered
25/05/2009
Date last updated
22/12/2021
Date data sharing statement initially provided
22/12/2021
Date results provided
22/12/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Improving Quality of Life (QOL) measurement for melanoma patients and their families
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Scientific title
Improving Quality of Life (QOL) measurement for melanoma patients and their families: Validity and reliability study of QOL insruments in an Australian sample
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Secondary ID [1]
1171
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01.09 MelQOL Research Study
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Universal Trial Number (UTN)
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Trial acronym
MEL-QOL Research Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Quality of Life (QOL) of melanoma patients and their families
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Condition category
Condition code
Cancer
5035
5035
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0
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Malignant melanoma
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is a questionnaire based study relying on participation at two levels. The first part of the study will involve conducting a set of focus group interviews with patients and their family members which will gather qualitative information about their experiences with melanoma diagnosis and treatment and how it has impacted on their quality of life (QOL). The focus group interviews would generally be 1-2 hour sessions and about 10 sessions in total would be held over a 3 month period (5 sessions for patients and 5 sessions for family members) depending on participant accrual.
The second part of the study will involve participants completing a set of quality of life (QOL) questionnaires in addition to a composite set of new quality of life (QOL) items developed from the first part of the study. A set of 5 questionnaires would be distributed to each participant (patients and familiy members) and they would submit completed questionnaires on the day of the trial visit.
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Intervention code [1]
4480
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Not applicable
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Generation and validation of new items for a melanoma-specific quality of life (QOL) instrument. The focus group interviews from the first part of the study will collect qualitative data on quality of life (QOL) isssues from patients and their family members. An interview template would be used to prompt discussions on quality of life (QOL) topics. Responses would be digitally recorded for transcription and qualitative analysis by the Biostatistician.
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Assessment method [1]
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Timepoint [1]
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6 months post-focus group interviews
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Secondary outcome [1]
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None
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Assessment method [1]
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Timepoint [1]
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None
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Eligibility
Key inclusion criteria
i) All melanoma patients attending clinics at Sydney Melanoma Unit (Melanoma Institute Australia), Sydney Cancer Centre (Royal Prince Alfred Hospital) and Westmead Cancer Care Centre (Westmead Hospital)
ii) Participants must have sufficient English fluency
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
i) Patients with current major psychiatric disturbance or mental illness
ii) Participants with insufficient English fluency
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Study design
Purpose
Psychosocial
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/07/2009
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Actual
1/06/2009
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Date of last participant enrolment
Anticipated
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Actual
31/12/2010
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Date of last data collection
Anticipated
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Actual
31/12/2010
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Sample size
Target
1060
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Accrual to date
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Final
1060
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
1657
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2060
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Sydney
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Address [1]
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Research Office
Level 6
Jane Foss Russell Building G02
Camperdown NSW 2006
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Country [1]
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Melanoma and Skin Cancer Trials
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Address
Level 2, 553 St Kilda Road, Melbourne, Victoria 3004
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
4448
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Country [1]
4448
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Other collaborator category [1]
660
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University
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Name [1]
660
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The Psycho-Oncology Co-operative Research Group (PoCoG)
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Address [1]
660
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School of Psychology
Brennan MacCallum Building A18
Camperdown NSW 2006
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Country [1]
660
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney South West Area Health Service (SSWAHS) Royal Prince Alfred Hospital Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
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Research Development Office Royal Prince Alfred Hospital Missenden Rd Camperdown NSW 2050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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27/05/2009
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Approval date [1]
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01/06/2009
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Ethics approval number [1]
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HREC/09/RPAH/124
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Summary
Brief summary
A melanoma-specific QoL questionnaire is being developed in a cross-cultural setting using a four phase process developed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. This study has shown that melanoma patients have important QoL issues that have been incorporated into a new cross-culturally validated instrument.
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Trial website
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Trial related presentations / publications
https://pubmed.ncbi.nlm.nih.gov/25325247/
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Public notes
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Contacts
Principal investigator
Name
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A/Prof A/Prof Julie Winstanley
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Address
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Australia and new Zealand Melanoma Trials Group / Melanoma Institute Australia incorporating Sydney Melanoma Unit Level 2 1A Eden St North Sydney NSW 2060
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Country
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Australia
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Phone
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+61 2 9911 7271
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Fax
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Email
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julie.winstanley@smu.org.au
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Contact person for public queries
Name
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A/Prof Julie Winstanley
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Address
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Australia and new Zealand Melanoma Trials Group / Melanoma Institute Australia incorporating Sydney Melanoma Unit
Level 2
1A Eden St
North Sydney NSW 2060
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Country
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Australia
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Phone
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+61 2 9911 7271
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Fax
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+61 2 9954 9435
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Email
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julie.winstanley@smu.org.au
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Contact person for scientific queries
Name
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A/Prof Julie Winstanley
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Address
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Australia and new Zealand Melanoma Trials Group / Melanoma Institute Australia incorporating Sydney Melanoma Unit
Level 2
1A Eden St
North Sydney NSW 2060
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Country
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Australia
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Phone
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+61 2 9911 7271
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Fax
3739
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+61 2 9954 9435
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Email
3739
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julie.winstanley@smu.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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