Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001667404
Ethics application status
Approved
Date submitted
29/11/2016
Date registered
2/12/2016
Date last updated
22/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Experience of a diagnosis of advanced melanoma: The perspective of bereaved family carers
Scientific title
A changing treatment paradigm: Bereaved family carers' perspectives of supportive and palliative care needs in advanced melanoma
Secondary ID [1] 290638 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced melanoma 301160 0
Condition category
Condition code
Cancer 300925 300925 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study explores the experiences of bereaved family carers of persons who died as a result of advanced melanoma. The study uses in-depth interviews to examine the issues from the carer perspective. Single interviews will be conducted and will range in duration from 30 minutes to 90 minutes.
Intervention code [1] 296523 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300341 0
Gain an in-depth understanding of experiences of health service provision of bereaved carers of patients with advanced melanoma from across three health care settings by carer interview.
Timepoint [1] 300341 0
One off Interview per carer will be conducted 2 to 18 months post bereavement.
Primary outcome [2] 300384 0
The ability of health care services to meet the support needs of patients and family carers will be determined by carer interview.
Timepoint [2] 300384 0
One off Interview per carer will be conducted 2 to 18 months post bereavement.
Secondary outcome [1] 329861 0
Elements and processes of service provision that contribute to an effective model of support are identified through carer interview.
Timepoint [1] 329861 0
One off Interview per carer will be conducted 2 to 18 months post bereavement.

Eligibility
Key inclusion criteria
Being a bereaved family carer who provided the majority of care for a person who died 2 to 18 months previously as a result of melanoma; being a bereaved family carer of person who received treatment at Peter MacCallum Cancer Centre, Melanoma Institute of Australia or Princess Alexandra Hospital; and being 18 years or older and English speaking.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Bereaved carers who indicate they do not wish to participate.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Qualitative research

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/05/2016
Date of last participant enrolment
Anticipated
28/02/2017
Actual
13/03/2017
Date of last data collection
Anticipated
15/03/2017
Actual
14/03/2017
Sample size
Target
24
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 7003 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 7004 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 7005 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 14735 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 14736 0
3000 - Melbourne
Recruitment postcode(s) [3] 14737 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 295074 0
Charities/Societies/Foundations
Name [1] 295074 0
Sigma Theta Tau International
Country [1] 295074 0
United States of America
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue
Kelvin Grove Qld 4059
Country
Australia
Secondary sponsor category [1] 293886 0
None
Name [1] 293886 0
Address [1] 293886 0
Country [1] 293886 0
Other collaborator category [1] 279328 0
Hospital
Name [1] 279328 0
Peter MacCallum Cancer Centre
Address [1] 279328 0
305 Grattan St
Melbourne VIC 3000
Country [1] 279328 0
Australia
Other collaborator category [2] 279329 0
Other
Name [2] 279329 0
Melanoma Institute of Australia (The Poche Centre)
Address [2] 279329 0
40 Rocklands Rd
North Sydney NSW 2060
Country [2] 279329 0
Australia
Other collaborator category [3] 279330 0
Hospital
Name [3] 279330 0
Princess Alexandra Hospital
Address [3] 279330 0
199 Ipswich Rd
Woolloongabba QLD 4102
Country [3] 279330 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296419 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 296419 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 296419 0
Australia
Date submitted for ethics approval [1] 296419 0
13/01/2016
Approval date [1] 296419 0
17/02/2016
Ethics approval number [1] 296419 0
HREC/16/QPAH/039
Ethics committee name [2] 296420 0
Queensland University of Technology
Ethics committee address [2] 296420 0
60 Musk Avenue
Kelvin Grove Qld 4059
Ethics committee country [2] 296420 0
Australia
Date submitted for ethics approval [2] 296420 0
01/03/2016
Approval date [2] 296420 0
21/03/2016
Ethics approval number [2] 296420 0
1600000212
Ethics committee name [3] 296421 0
Peter MacCallu,m Cancer Centre
Ethics committee address [3] 296421 0
305 Grattan St
Melbourne VIC 3000
Ethics committee country [3] 296421 0
Australia
Date submitted for ethics approval [3] 296421 0
07/03/2016
Approval date [3] 296421 0
16/03/2016
Ethics approval number [3] 296421 0
SSA/16/PMCC/35
Ethics committee name [4] 296422 0
Melanoma Institute of Australia
Ethics committee address [4] 296422 0
The Poche Centre
40 Rocklands Road
Wollstonecraft NSW 2065
Ethics committee country [4] 296422 0
Australia
Date submitted for ethics approval [4] 296422 0
01/11/2016
Approval date [4] 296422 0
11/11/2016
Ethics approval number [4] 296422 0
MIA2015/172

Summary
Brief summary
The primary purpose of this study is to identify supportive and palliative care needs from the perspective of bereaved family carers of deceased advanced melanoma patients from diagnosis of advanced disease to death.

Who is it for?
You may be eligible to participate in this study if you are aged 18 or over, are English-speaking and were the main carer of a person who died 2 to 18 months previously as a result of melanoma.

Study details
All participants in this study will complete a single 30-90 minute interview about supportive care needs from diagnosis to death of a family member with advanced melanoma. It is hoped that from these interviews, researchers will identify the supportive care needs of these individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70814 0
Dr Jenny Fox
Address 70814 0
Queensland University of Technology
60 Musk Avenue
Kelvin Grove Qld 4059
Country 70814 0
Australia
Phone 70814 0
+61 7 31380136
Fax 70814 0
Email 70814 0
[email protected]
Contact person for public queries
Name 70815 0
Dr Jenny Fox
Address 70815 0
Queensland University of Technology
60 Musk Avenue
Kelvin Grove Qld 4059
Country 70815 0
Australia
Phone 70815 0
+61 7 31380136
Fax 70815 0
Email 70815 0
[email protected]
Contact person for scientific queries
Name 70816 0
Dr Jenny Fox
Address 70816 0
Queensland University of Technology
60 Musk Avenue
Kelvin Grove Qld 4059
Country 70816 0
Australia
Phone 70816 0
+61 7 31380136
Fax 70816 0
Email 70816 0
[email protected]

No information has been provided regarding IPD availability


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.