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Trial registered on ANZCTR
Registration number
ACTRN12611000504910
Ethics application status
Approved
Date submitted
12/05/2011
Date registered
13/05/2011
Date last updated
7/09/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
A prospective longitudinal cohort study describing quality of life in patients undergoing pulmonary metastasectomy for metastatic sarcoma
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Scientific title
A prospective longitudinal cohort study describing quality of life in patients undergoing pulmonary metastasectomy for metastatic sarcoma
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Secondary ID [1]
262158
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Australasian Sarcoma Study Group Number 06-11 (ASSG06-11PMR)
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Universal Trial Number (UTN)
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Trial acronym
ASSG06-11PMR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
To evaluate the health-related quality of life (HRQOL) associated with pulmonary metastasectomy (PM) from metastatic sarcoma
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Condition category
Condition code
Cancer
259482
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0
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Sarcoma (also see 'Bone') - soft tissue
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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
No intervention, Quality of Life Study.
Patients undergoing a PM for metastatic sarcoma will be invited to complete HRQOL Assessments prior to their surgery and at certain time points after their surgery for up to three years after their PM surgery.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
No control treatment, Quality of Life Study.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To evaluate the health-related quality of life (HRQOL) associated with pulmonary metastasectomy (PM) (specifically patient-reported dysponea, cough, chest pain, fatigue, physical functioning, role functioning, social functioning, emotional functioning and overall HRQOL).
HRQOL will be evaluate via The Patient-Reported Outcomes Measurement Information System (PROMIS) which is an electronic system aimed at improving and standardising measurement of patient-reported outcomes (PROs).
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Assessment method [1]
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Timepoint [1]
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Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death.
Patient will be asked to complete HRQOL Assessments prior to their PM surgery, after discharge from hospital, 3-4 weeks after PM surgery, 3-4 months after PM surgery, 8-9 months after PM surgery, 12 months after PM surgery, 2 years after PM surgery and 3 years after PM surgery.
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Secondary outcome [1]
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To evaluate overall post-metastasectomy survival by evaluating the data recorded with HRQOL Assessment combined with data recorded in ACCORD. ACCORD is a health data based used by hospitals to record patient information such as surgery details and local of samples.
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Assessment method [1]
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Timepoint [1]
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Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death.
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Secondary outcome [2]
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To describe the patterns of care of patients having PM and peri-operative systemic therapy via ACCORD which is a health data based used by hospitals to record patient information such as surgery details and local of samples.
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Assessment method [2]
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Timepoint [2]
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Data available two years after accrual of the last patient will be analysed in the first instance..
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Secondary outcome [3]
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To identify prognostic factors associated with survival via ACCORD and HRQOL assessments.
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Assessment method [3]
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Timepoint [3]
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Data available two years after accrual of the last patient will be analysed in the first instance.
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Secondary outcome [4]
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To assess the psychometric properties of the PROMIS HRQOL measurement system relative to the EORTC HRQOL measurement system.
This is achieved by comparing the data measured in PROMIS HRQOL measurement system to data measured in the EORTC HRQOL measurement system.
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Assessment method [4]
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Timepoint [4]
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Data available two years after accrual of the last patient will be analysed in the first instance.
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Secondary outcome [5]
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Relapse free survival based on clinical assessment and CT scans.
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Assessment method [5]
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Timepoint [5]
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Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death
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Secondary outcome [6]
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Site of reccurence after PM standard care follow up with treating doctor which is captured in ACCORD
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Assessment method [6]
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Timepoint [6]
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Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death
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Secondary outcome [7]
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Quality time without symptoms of disease or toxicity (QTWIST)
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Assessment method [7]
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Timepoint [7]
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Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death
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Secondary outcome [8]
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Surgical adverse events such as (death at 30 day follow up,
date of hospital discharge after PM, prolonged air leak
>7 days post-operatively, chest wall pain at 6 months
post-operatively, PEFR pre-operatively and postoperatively
at 3-4 weeks and 6 months), chemotherapy
toxicities, radiotherapy toxicities.
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Assessment method [8]
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Timepoint [8]
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Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death
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Eligibility
Key inclusion criteria
1. Metastatic bone or soft tissue sarcoma
2. Lung-only metastases
3. Planned pulmonary metastasectomy
4. Age greater than or equal to 18 years
5. Signed informed consent
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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
No exclusion criteria
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Study design
Purpose
Psychosocial
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Duration
Longitudinal
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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
Recruiting
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Date of first participant enrolment
Anticipated
20/04/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Cancer Australia
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Address [1]
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PO Box 1201, DICKSON ACT 2602
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Country [1]
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Australia
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Funding source category [2]
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Other Collaborative groups
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Name [2]
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Australasian Sarcoma Study Group (ASSG)
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Address [2]
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Peter MacCallum Cancer Centre
Locked Bag 1 A'Becket St
East Melbourne
Victoria Australia 8006
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Country [2]
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Australia
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Funding source category [3]
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Other Collaborative groups
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Name [3]
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Psycho-oncology Co-operative Research Group (PoCoG)
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Address [3]
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School of Psychology
Brennan MacCallum Building (A18)
The University of Sydney, NSW 2006
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Country [3]
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Australasian Sarcoma Study Group (ASSG)
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Address
Peter MacCallum Cancer Centre
Locked Bag 1 A'Becket St
East Melbourne
Victoria Australia 8006
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Country
Australia
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Psycho-oncology Co-operative Research Group (PoCoG)
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Address [1]
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Psycho-oncology Co-operative Research Group (PoCoG)
School of Psychology
Brennan MacCallum Building (A18)
The University of Sydney, NSW 2006
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Country [1]
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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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Peter MacCallum Cancer Centre Ethics Committee
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Ethics committee address [1]
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Locked Bag 1 A'Beckett St
East Melbourne
Victoria 8006
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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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04/11/2010
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Approval date [1]
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14/01/2011
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Ethics approval number [1]
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E39-10
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Summary
Brief summary
Evaluate the Health Related Quality of Life (HRQOL) associated with pulmonary metastasectomy (PM) (specifically: dyspnoea, cough, chest pain, pain interference, fatigue, physical functioning, role functioning, social functioning, satisfaction with social discretionary activities and satisfaction with social roles, emotional functioning, depression, anxiety and overall HRQOL).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Rachel Dear
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Address
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Medical Oncology Clinical Research Fellow
Room 391, Blackburn Building, D06
The University of Sydney NSW 2006
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Country
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Australia
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Phone
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+61 2 9351 6171
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Fax
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+61 2 9351 4317
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Rachel Dear
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Address
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Medical Oncology Clinical Research Fellow
Room 391, Blackburn Building, D06
The University of Sydney NSW 2006
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Country
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Australia
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Phone
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+61 2 9351 6171
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Fax
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+61 2 9351 4317
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Email
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[email protected]
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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.
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