Trial Review

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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 information initially 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
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
Secondary ID [1] 1171 0
01.09 MelQOL Research Study
Universal Trial Number (UTN)
Trial acronym
MEL-QOL Research Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of Life (QOL) of melanoma patients and their families 4713 0
Condition category
Condition code
Cancer 5035 5035 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 4480 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5874 0
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.
Timepoint [1] 5874 0
6 months post-focus group interviews
Secondary outcome [1] 241904 0
None
Timepoint [1] 241904 0
None

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Patients with current major psychiatric disturbance or mental illness

ii) Participants with insufficient English fluency

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
31/12/2010
Date of last data collection
Anticipated
Actual
31/12/2010
Sample size
Target
1060
Accrual to date
Final
1060
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 1657 0
2060

Funding & Sponsors
Funding source category [1] 4919 0
University
Name [1] 4919 0
University of Sydney
Country [1] 4919 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Melanoma and Skin Cancer Trials
Address
Level 2, 553 St Kilda Road, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 4448 0
None
Name [1] 4448 0
Address [1] 4448 0
Country [1] 4448 0
Other collaborator category [1] 660 0
University
Name [1] 660 0
The Psycho-Oncology Co-operative Research Group (PoCoG)
Address [1] 660 0
School of Psychology
Brennan MacCallum Building A18
Camperdown NSW 2006
Country [1] 660 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6955 0
Sydney South West Area Health Service (SSWAHS) Royal Prince Alfred Hospital Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 6955 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Ethics committee country [1] 6955 0
Australia
Date submitted for ethics approval [1] 6955 0
27/05/2009
Approval date [1] 6955 0
01/06/2009
Ethics approval number [1] 6955 0
HREC/09/RPAH/124

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.
Trial website
Trial related presentations / publications
https://pubmed.ncbi.nlm.nih.gov/25325247/
Public notes

Contacts
Principal investigator
Name 29564 0
A/Prof A/Prof Julie Winstanley
Address 29564 0
Australia and new Zealand Melanoma Trials Group / Melanoma Institute Australia incorporating Sydney Melanoma Unit Level 2 1A Eden St North Sydney NSW 2060
Country 29564 0
Australia
Phone 29564 0
+61 2 9911 7271
Fax 29564 0
Email 29564 0
[email protected]
Contact person for public queries
Name 12811 0
A/Prof A/Prof Julie Winstanley
Address 12811 0
Australia and new Zealand Melanoma Trials Group / Melanoma Institute Australia incorporating Sydney Melanoma Unit
Level 2
1A Eden St
North Sydney NSW 2060
Country 12811 0
Australia
Phone 12811 0
+61 2 9911 7271
Fax 12811 0
+61 2 9954 9435
Email 12811 0
[email protected]
Contact person for scientific queries
Name 3739 0
A/Prof A/Prof Julie Winstanley
Address 3739 0
Australia and new Zealand Melanoma Trials Group / Melanoma Institute Australia incorporating Sydney Melanoma Unit
Level 2
1A Eden St
North Sydney NSW 2060
Country 3739 0
Australia
Phone 3739 0
+61 2 9911 7271
Fax 3739 0
+61 2 9954 9435
Email 3739 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://pubmed.ncbi.nlm.nih.gov/25325247/ Feb 201... [More Details]

Documents added automatically
No additional documents have been identified.