Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000636651
Ethics application status
Approved
Date submitted
6/06/2014
Date registered
17/06/2014
Date last updated
11/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health Related Quality of Life in Malignant Mesothelioma
Scientific title
An Observational Study of Health-related Quality of Life in People with Malignant Mesothelioma
Secondary ID [1] 284736 0
Nil
Universal Trial Number (UTN)
Trial acronym
HQOL in MM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Mesothelioma 292090 0
Health Related Quality of Life 292091 0
Anxiety 292092 0
Depression 292093 0
Supportive Care Needs 292094 0
Nutritional Status 292095 0
Functional Status 292096 0
Inflammatory Response 292097 0
Condition category
Condition code
Cancer 292433 292433 0 0
Lung - Mesothelioma
Mental Health 292484 292484 0 0
Anxiety
Mental Health 292485 292485 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
Participants involved in primary study will complete a range of patient reported outcome measures at 6-12 week intervals for up to 2 years. These measures will include assessment of health related quality of life, anxiety and depression and unmet supportive care needs. Optional sub-studies will involve nutritional assessment, functional assessment and donation of additional blood for the analysis of inflammatory markers.
Intervention code [1] 289520 0
Not applicable
Comparator / control treatment
No control group or comparator will be observed during the course of this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292310 0
Health related quality of life

Instrument(s): EORTC QLQ-C30 and LC13, LCSS-Meso
Timepoint [1] 292310 0
Baseline, at regular follow up intervals (6-12 weeks) and following change in disease or treatment status for up to 2 years.
Secondary outcome [1] 308694 0
Anxiety and Depression

Instrument(s): Hospital Anxiety and Depression Scale
Timepoint [1] 308694 0
Baseline, at regular follow up intervals (6-12 weeks) and following change in disease or treatment status for up to 2 years.
Secondary outcome [2] 308695 0
Functional Status

Instrument(s): 6 minute walk test
Timepoint [2] 308695 0
Baseline, at regular follow up intervals (6-12 weeks) and following change in disease or treatment status for up to 2 years
Secondary outcome [3] 308696 0
Nutritional Status

Instrument(s): Abridged Patient Generated Subjective Global Assessment (abPG-SGA) OR Patient Generated Subjective Global Assessment (PG-SGA), Skin Fold Measurements and Grip Strength
Timepoint [3] 308696 0
Baseline, at regular follow up intervals (6-12 weeks) and following change in disease or treatment status for up to 2 years.
Secondary outcome [4] 308697 0
Inflammatory Response

Instrument(s): Serum level of cytokines
Timepoint [4] 308697 0
Baseline, and following change in disease or treatment status for up to 2 years.
Secondary outcome [5] 308698 0
Glasgow Prognostic Score

Instrument(s): Albumin, CRP and NLR
Timepoint [5] 308698 0
Baseline, at regular follow up intervals (6-12 weeks) and following change in disease or treatment status for up to 2 years.
Secondary outcome [6] 308699 0
Supportive Care Needs

Instrument(s): Supportive Care Needs Survey Short Form (SCNS-34)
Timepoint [6] 308699 0
Baseline, at regular follow up intervals (6-12 weeks) and following change in disease or treatment status for up to 2 years.
Secondary outcome [7] 308700 0
Health Literacy

Instrument(s): Health Literacy 2 Single Item Questions
Timepoint [7] 308700 0
Baseline, at regular follow up intervals (6-12 weeks) and following change in disease or treatment status for up to 2 years.
Secondary outcome [8] 308701 0
Eastern Co-operative Oncology Group (ECOG) Performance Status

Instrument(s): Clinician rated
Timepoint [8] 308701 0
Baseline, at regular follow up intervals (6-12 weeks) and following change in disease or treatment status for up to 2 years.

Eligibility
Key inclusion criteria
1. Patients with a diagnosis of malignant mesothelioma
2. Able to comply with planned procedures and provide written evidence of informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with insufficient English will be excluded from patient reported outcome component of the study but can still participate in the other aspects of the study.
2. People unavailable or unwilling to consent to ongoing follow-up

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Primary analysis will describe the trajectory of change in Health-related Quality of Life from baseline by time and treatment group using linear mixed models.
Associations of secondary endpoints will be evaluated by entering each of the factors as time-varying covariates in separate linear mixed models.
Secondary endpoints will be evaluated in an exploratory, hypothesis-generating analysis to avoid over interpreting the data. They will be compared between treatment groups and possible relationships of these endpoints with Health-related Quality of Life assessed at baseline and at various points of treatment follow up. Correlation between each primary and secondary endpoint will be evaluated.
Change in Quality of Life during disease progression will be measured by a mean change score, calculated by subtracting patient baseline scores from the mean of their scores at follow-up. Between group differences will be summarised by the average of patient’s mean change scores and compared between with a mean change of zero using t-tests.
Multiple regression with be used to assess the effect of potential prognostic factors on Health-related Quality of Life.
Overall survival is an exploratory endpoint and will be described by the Kaplan-Meier method. A stratified log-rank test will be used to describe overall survival between the groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2014
Actual
22/05/2014
Date of last participant enrolment
Anticipated
1/05/2017
Actual
10/07/2017
Date of last data collection
Anticipated
Actual
31/10/2017
Sample size
Target
200
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 2587 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 2588 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 2589 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [4] 2590 0
Northern Cancer Institute - Frenchs Forest - Frenchs Forest
Recruitment hospital [5] 2591 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 2592 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [7] 2593 0
Westmead Hospital - Westmead
Recruitment hospital [8] 2594 0
Prince of Wales Hospital - Randwick
Recruitment hospital [9] 2595 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [10] 2596 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [11] 2597 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [12] 2598 0
The Canberra Hospital - Garran
Recruitment hospital [13] 2599 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [14] 2600 0
The Prince Charles Hospital - Chermside
Recruitment hospital [15] 2601 0
Nepean Hospital - Kingswood
Recruitment hospital [16] 2602 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [17] 2603 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [18] 2604 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [19] 2605 0
Orange Health Service - Orange
Recruitment postcode(s) [1] 8260 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 8261 0
2050 - Camperdown
Recruitment postcode(s) [3] 8263 0
2050 - Missenden Road
Recruitment postcode(s) [4] 8264 0
2065 - St Leonards
Recruitment postcode(s) [5] 8265 0
2170 - Liverpool
Recruitment postcode(s) [6] 8266 0
2560 - Campbelltown
Recruitment postcode(s) [7] 8267 0
2145 - Westmead
Recruitment postcode(s) [8] 8268 0
2031 - Randwick
Recruitment postcode(s) [9] 8269 0
2298 - Waratah
Recruitment postcode(s) [10] 8270 0
3084 - Heidelberg
Recruitment postcode(s) [11] 8271 0
6009 - Nedlands
Recruitment postcode(s) [12] 8272 0
2605 - Garran
Recruitment postcode(s) [13] 8273 0
4032 - Chermside
Recruitment postcode(s) [14] 8274 0
2747 - Kingswood
Recruitment postcode(s) [15] 8275 0
2076 - Wahroonga
Recruitment postcode(s) [16] 8276 0
5011 - Woodville
Recruitment postcode(s) [17] 8277 0
2830 - Dubbo
Recruitment postcode(s) [18] 8278 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 289367 0
Government body
Name [1] 289367 0
Cancer Institue NSW
Country [1] 289367 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 288052 0
None
Name [1] 288052 0
Address [1] 288052 0
Country [1] 288052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291133 0
Sydney Local Health District CRGH (EC00118)
Ethics committee address [1] 291133 0
Concord Repatriation and General Hospital
Level 1, Building 75
Hospital Road
Concord NSW
2139
Ethics committee country [1] 291133 0
Australia
Date submitted for ethics approval [1] 291133 0
Approval date [1] 291133 0
16/08/2013
Ethics approval number [1] 291133 0
CH62/6/2013-092 J Vardy

Summary
Brief summary
This study aims to describe the symptoms, quality of life and supportive care needs of people diagnosed with malignant mesothelioma (MM). Additionally, we aim to describe the nutritional and functional status of people with MM, and to assess the relationship between psychological factors (anxiety and depression) and quality of life and other outcomes. Who is it for? You may be eligible to joint this study if you are aged 18 years or more and have been diagnosed with malignant mesothelioma. Study details Participants in this study will be asked to complete a range of patient reported outcome measures at 6-12 week intervals for up to 2 years. These measures will include assessment of health related quality of life, anxiety and depression and unmet supportive care needs. Optional sub-studies will involve nutritional assessment, functional assessment and donation of additional blood for the analysis of inflammatory markers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48954 0
A/Prof Janette Vardy
Address 48954 0
Dept of Medical Oncology
Concord Repatriation General Hospital
Hospital Rd, Concord NSW 2139
Country 48954 0
Australia
Phone 48954 0
61297675000
Fax 48954 0
61297679860
Email 48954 0
[email protected]
Contact person for public queries
Name 48955 0
Mr Jason Fowler
Address 48955 0
Asbestos Diseases Research Institute
PO Box 3628
Rhodes NSW 2138
Country 48955 0
Australia
Phone 48955 0
 61297679847
Fax 48955 0
61297679860
Email 48955 0
[email protected]
Contact person for scientific queries
Name 48956 0
A/Prof Janette Vardy
Address 48956 0
Dept of Medical Oncology
Concord Repatriation General Hospital
Hospital Rd, Concord NSW 2139
Country 48956 0
Australia
Phone 48956 0
61297675000
Fax 48956 0
61297679860
Email 48956 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

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