Trial Review

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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
Scientific title
A prospective longitudinal cohort study describing quality of life in patients undergoing pulmonary metastasectomy for metastatic sarcoma
Secondary ID [1] 262158 0
Australasian Sarcoma Study Group Number 06-11 (ASSG06-11PMR)
Universal Trial Number (UTN)
Trial acronym
ASSG06-11PMR
Linked study record

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 261334 0
Condition category
Condition code
Cancer 259482 259482 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 264180 0
Not applicable
Comparator / control treatment
No control treatment, Quality of Life Study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262291 0
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).
Timepoint [1] 262291 0
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.
Secondary outcome [1] 273472 0
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.
Timepoint [1] 273472 0
Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death.
Secondary outcome [2] 273473 0
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.
Timepoint [2] 273473 0
Data available two years after accrual of the last patient will be analysed in the first instance..
Secondary outcome [3] 273474 0
To identify prognostic factors associated with survival via ACCORD and HRQOL assessments.
Timepoint [3] 273474 0
Data available two years after accrual of the last patient will be analysed in the first instance.
Secondary outcome [4] 273475 0
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.
Timepoint [4] 273475 0
Data available two years after accrual of the last patient will be analysed in the first instance.
Secondary outcome [5] 276283 0
Relapse free survival based on clinical assessment and CT scans.
Timepoint [5] 276283 0
Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death
Secondary outcome [6] 276284 0
Site of reccurence after PM standard care follow up with treating doctor which is captured in ACCORD
Timepoint [6] 276284 0
Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death
Secondary outcome [7] 276285 0
Quality time without symptoms of disease or toxicity (QTWIST)
Timepoint [7] 276285 0
Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death
Secondary outcome [8] 276286 0
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.
Timepoint [8] 276286 0
Patients will be recruited over 2 years and will be followed up for 3 years after accrual of the last patient or until death

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265058 0
Government body
Name [1] 265058 0
Cancer Australia
Country [1] 265058 0
Australia
Funding source category [2] 265059 0
Other Collaborative groups
Name [2] 265059 0
Australasian Sarcoma Study Group (ASSG)
Country [2] 265059 0
Australia
Funding source category [3] 265064 0
Other Collaborative groups
Name [3] 265064 0
Psycho-oncology Co-operative Research Group (PoCoG)
Country [3] 265064 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Sarcoma Study Group (ASSG)
Address
Peter MacCallum Cancer Centre
Locked Bag 1 A'Becket St
East Melbourne
Victoria Australia 8006
Country
Australia
Secondary sponsor category [1] 264156 0
Other Collaborative groups
Name [1] 264156 0
Psycho-oncology Co-operative Research Group (PoCoG)
Address [1] 264156 0
Psycho-oncology Co-operative Research Group (PoCoG)
School of Psychology
Brennan MacCallum Building (A18)
The University of Sydney, NSW 2006
Country [1] 264156 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267045 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 267045 0
Locked Bag 1 A'Beckett St
East Melbourne
Victoria 8006
Ethics committee country [1] 267045 0
Australia
Date submitted for ethics approval [1] 267045 0
04/11/2010
Approval date [1] 267045 0
14/01/2011
Ethics approval number [1] 267045 0
E39-10

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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32321 0
Address 32321 0
Country 32321 0
Phone 32321 0
Fax 32321 0
Email 32321 0
Contact person for public queries
Name 15568 0
Dr Rachel Dear
Address 15568 0
Medical Oncology Clinical Research Fellow
Room 391, Blackburn Building, D06
The University of Sydney NSW 2006
Country 15568 0
Australia
Phone 15568 0
+61 2 9351 6171
Fax 15568 0
+61 2 9351 4317
Email 15568 0
rachel.dear@sydney.edu.au
Contact person for scientific queries
Name 6496 0
Dr Rachel Dear
Address 6496 0
Medical Oncology Clinical Research Fellow
Room 391, Blackburn Building, D06
The University of Sydney NSW 2006
Country 6496 0
Australia
Phone 6496 0
+61 2 9351 6171
Fax 6496 0
+61 2 9351 4317
Email 6496 0
rachel.dear@sydney.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided


Results publications and other study-related documents

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