Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000063819
Ethics application status
Approved
Date submitted
23/10/2020
Date registered
27/01/2021
Date last updated
17/01/2022
Date data sharing statement initially provided
27/01/2021
Date results information initially provided
17/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The QUEST initiative: QUality of life Evaluation STudy:
Assessing Health Related Quality of Life in patients receiving medicinal cannabis.
Scientific title
The QUEST initiative: QUality of life Evaluation STudy: Assessing Health Related Quality of Life in patients receiving medicinal cannabis.
Secondary ID [1] 302615 0
The University of Sydney CT28838
Universal Trial Number (UTN)
U1111-1260-0972
Trial acronym
QUEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Disease 319506 0
Chronic Pain 319507 0
Neurological Disorders 319508 0
Condition category
Condition code
Neurological 317464 317464 0 0
Other neurological disorders
Mental Health 317465 317465 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This research will evaluate patient-reported outcomes in patients with chronic conditions being prescribed medicinal cannabis under the Special Access Scheme across clinics within Australia. Patients will be assessed at baseline and every 1-2 months over a period of one year, using validated questionnaires to measure quality of life, anxiety and depression, fatigue, sleep, pain, work performance, and motor function, depending on the patient's health indication.
Intervention code [1] 318900 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325497 0
Changes in health-related quality of life, for a large cohort receiving medicinal cannabis.
Assessments include EQ-5D; EORTC QLQ-C30; Patient global impression of change (PGIC).
Timepoint [1] 325497 0
assessments completed at baseline, 2 weeks (titration), then monthly to 3 months
Primary outcome [2] 325788 0
Changes in depression for a large cohort receiving medicinal cannabis.
Assessed with DASS21;
Timepoint [2] 325788 0
assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.
Primary outcome [3] 325791 0
Changes in sleep for a large cohort receiving medicinal cannabis.
Assessed with PROMIS Short Form v1.0 Sleep Disturbance 8b
Timepoint [3] 325791 0
assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.
Secondary outcome [1] 388172 0
Changes in pain for patients accessing medicinal cannabis for Chronic Pain.
Assessments include EQ-5D; Patient global impression of change (PGIC); PROMIS Scale v1.0 - Pain Intensity 3a; PROMIS Short Form v1.0 - Pain Interference 8a.
Timepoint [1] 388172 0
assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.
Secondary outcome [2] 388173 0
Changes in health-related quality of life, for a large cohort receiving medicinal cannabis - 12 month follow-up.

Assessments include EQ-5D; EORTC QLQ-C30; DASS21; Patient global impression of change (PGIC); PROMIS Fatigue 13a FACIT-Fat; PROMIS Short Form v1.0 Sleep Disturbance 8b.
Timepoint [2] 388173 0
assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.
Secondary outcome [3] 388174 0
Healthcare resource use assessed with study specific questionnaire adapted from the 'annotated cost questionnaire for completion by patients' HERU Discussion Paper.
Timepoint [3] 388174 0
assessments completed at baseline, monthly to 3 months, then every 2 months up to one year.
Secondary outcome [4] 389139 0
Changes in health impact on work performance for patients accessing medicinal cannabis who indicate they are working or would normally be working. Assessed using the absenteeism and presenteeism questions of the World Health Organization’s Heath and Work Performance Questionnaire (HPQ).
Timepoint [4] 389139 0
assessments completed at baseline, monthly to 3 months, then every 2 months up to one year.
Secondary outcome [5] 389145 0
Compare differences in patient reported outcomes between patients accessing medicinal cannabis for movement disorder.
Composite outcome using assessments: Neuro-QoL Short Form v2.0 – HDQLIFE – Chorea 6a; Neuro-QoL v1.0 – Upper Extremity Function (Fine Motor, ADL); Patient global impression of change (PGIC).
Timepoint [5] 389145 0
assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.
Secondary outcome [6] 389146 0
Changes in other prescribed medication use assessed with study specific questionnaire adapted from the 'annotated cost questionnaire for completion by patients' HERU Discussion Paper.
Timepoint [6] 389146 0
assessments completed at baseline, monthly to 3 months, then every 2 months up to one year.
Secondary outcome [7] 389963 0
Changes in fatigue for a large cohort receiving medicinal cannabis.
Assessed with PROMIS Fatigue 13a FACIT-Fat
Timepoint [7] 389963 0
assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.
Secondary outcome [8] 389964 0
Changes in anxiety for a large cohort receiving medicinal cannabis.
Assessed with DASS21;
Timepoint [8] 389964 0
assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.

Eligibility
Key inclusion criteria
All of the following must be satisfied for enrolment in the study:
• adult patients (aged 18 years and over)
• patient has been identified as eligible to receive medicinal cannabis under the special access scheme (or equivalent in other countries and jurisdictions) by a doctor at participating centres registered to prescribe medicinal cannabis
• patient is able to read and understand English
• patient is able to provide informed consent
• patient has not started medicinal cannabis therapy, or the patient started medicinal cannabis therapy within the previous 2 days (we expect no therapeutic benefit within 2 days)
• patient has not received prescribed medicinal cannabis therapy in the previous 4 weeks (excluding previous 2 days)
• patient has a life-expectancy >3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if any of the following criteria apply:
• are unconscious or confused
• have cognitive impairment
• are pregnant
• are unable to speak, read and/or write in English
• are denied access to medicinal cannabis under the relevant Special Access Scheme for their country of registration
• are unable to provide informed consent
• are already receiving medicinal cannabis treatment for more than 2 days
• have received prescription medicinal cannabis within the last 4 weeks (excluding previous 2 days)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Our aim is to recruit a large broad and representative sample of medicinal cannabis users. As such, we will include every eligible patient treated at each participating centre during a 12 month recruitment period. This large real-world cohort will enable several important analyses exploring differences in patient reported outcomes (PROs) between disease groups commonly treated with medicinal cannabis.
Minimum sample required for primary objective (change over time): Following guidelines for QLQ-C30, and allowing for 20% loss to follow-up, a sample size of 2142 is required with a minimum follow-up of 3 months. This sample size provides 95% power to detect the smallest effect size threshold of 0.1 for the insomnia domain, using a two-sided significance level of 1%.

PRO analyses will explore change over time using linear mixed models. Subgroup analyses will compare differences in PROs between underlying conditions, dose, and duration of pain, over time.
The economic evaluation will use the collected data around pharmaceutical and other medical costs to explore the drivers of patient-level cost. As this project is not proposing a comparative randomised study, we are not proposing to conduct formal economic evaluation resulting in a cost per quality-adjusted life year (QALY). We will instead use baseline resource use as an indicator of typical care, and contrast resource use through the study with baseline data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
27/11/2020
Date of last participant enrolment
Anticipated
30/11/2021
Actual
24/12/2021
Date of last data collection
Anticipated
30/12/2022
Actual
Sample size
Target
2142
Accrual to date
Final
2804
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 307047 0
Commercial sector/Industry
Name [1] 307047 0
Little Green Pharma Ltd
Country [1] 307047 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Little Green Pharma Ltd.
Address
PO Box 690 West Perth WA 6872
Country
Australia
Secondary sponsor category [1] 307617 0
None
Name [1] 307617 0
Address [1] 307617 0
Country [1] 307617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307172 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 307172 0
Research Integrity and Ethics Administration | Research Portfolio
THE UNIVERSITY OF SYDNEY
Level 3, Administration Building (F23) | The University of Sydney | NSW | 2006
Ethics committee country [1] 307172 0
Australia
Date submitted for ethics approval [1] 307172 0
11/08/2020
Approval date [1] 307172 0
11/11/2020
Ethics approval number [1] 307172 0
2020/589

Summary
Brief summary
The past two decades have seen an increase in medicinal cannabis research, which has consequently led to a number of countries, including Australia, introducing legislations allowing its use. Research has shown that medicinal cannabis can reduce chronic pain, neuropathic pain, cancer pain, chemotherapy-induced nausea, spasticity in Multiple Sclerosis, epileptic seizures, depression, and anxiety, as well as improve sleep, and reduce opioid prescription numbers.
In Australia, it is estimated that more than 15% of the adult population live with persistent chronic pain or recurring pain lasting longer than 6 months. Neuropathic pain is experienced by approximately 8% of the population, and about 86% of patients with Multiple Sclerosis. It is associated with higher rates of unemployment, poor physical, psychological, and social functioning, significantly impaired health-related quality of life (HRQL) and sleep, and higher depression and anxiety than those with other chronic pain, and those without pain. Less than 35% of patients respond to conventional therapy, with others often receiving incomplete pain relief, which is commonly accompanied by conventional treatment-related side effects.
Patient reported outcomes (PROs) can include symptoms, function, health-related quality of life (HRQL), and perceptions of treatment. In contrast to life-threatening conditions where survival endpoints may dominate HRQL considerations, PROs play a key role in chronic conditions, and are regarded as the gold standard for the assessment of pain. Collecting PROs with validated and reliable standardised questionnaires also allows comparisons between groups, and over time.
Health care professionals need to be able to monitor the outcome of any treatment, and the existing evidence on PROs for medicinal cannabis has limitations such as; small sample sizes, lack of data collected over time, not using validated questionnaires, or not using comprehensive questionnaires for the condition treated. Participants studied under the controlled environment of randomised clinical trials may not always be representative of the entire spectrum of disease and health status seen in the general population currently accessing medicinal cannabis. Therefore, while clinical trials provide evidence of the efficacy of medicinal cannabis, the true gauge of how effective it is in practice comes from real-world evidence. The proposed research will assess quality of life in a large sample of people accessing medical cannabis over a 12 month period, using validated and comprehensive questionnaires relevant to their health condition.
Trial website
Trial related presentations / publications
Public notes
This study will only assess patients receiving medicinal products manufactured/distributed by Little Green Pharma Ltd. (LGP), as this will enable accurate measurement and comparison of the dosing, potency, and mode of administration of medicinal cannabis within and between health conditions.

Contacts
Principal investigator
Name 106286 0
Dr Claudia Rutherford
Address 106286 0
Chris O'Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006 AUSTRALIA
Country 106286 0
Australia
Phone 106286 0
+61296271583
Fax 106286 0
Email 106286 0
claudia.rutherford@sydney.edu.au
Contact person for public queries
Name 106287 0
Ms Margaret-Ann Tait
Address 106287 0
Chris O'Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006 AUSTRALIA
Country 106287 0
Australia
Phone 106287 0
+61296271558
Fax 106287 0
Email 106287 0
margaret-ann.tait@sydney.edu.au
Contact person for scientific queries
Name 106288 0
Ms Margaret-Ann Tait
Address 106288 0
Chris O'Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006 AUSTRALIA
Country 106288 0
Australia
Phone 106288 0
+61296271558
Fax 106288 0
Email 106288 0
margaret-ann.tait@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD and related data dictionaries are/will be available
When will data be available (start and end dates)?
Access to de-identified datasets will be available after publication of final results - no end date determined.
Available to whom?
Access to de-identified datasets will be for researchers who provide a methodologically sound proposal, and on a case-by-case basis at the discretion of Primary Sponsor and chief investigator, and may be contingent on certain terms and conditions being met by the applicant (e.g. human research ethics clearance).
Available for what types of analyses?
Mediated access to researchers for the purpose of data pooling exercises to achieve the aims in the approved proposal, and for IPD meta-analyses.
How or where can data be obtained?
A record of the de-identified dataset will be created in the University Research Data Registry.


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.