ANZCTR - Registration

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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

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]

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

Chronic Pain

Neurological Disorders

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

assessments completed at baseline, 2 weeks (titration), then monthly to 3 months

Primary outcome [2]

Changes in depression for a large cohort receiving medicinal cannabis.
Assessed with DASS21;

Timepoint [2]

assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.

Primary outcome [3]

Changes in sleep for a large cohort receiving medicinal cannabis.
Assessed with PROMIS Short Form v1.0 Sleep Disturbance 8b

Timepoint [3]

assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.

Secondary outcome [1]

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]

assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.

Secondary outcome [2]

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]

assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.

Secondary outcome [3]

Healthcare resource use assessed with study specific questionnaire adapted from the 'annotated cost questionnaire for completion by patients' HERU Discussion Paper.

Timepoint [3]

assessments completed at baseline, monthly to 3 months, then every 2 months up to one year.

Secondary outcome [4]

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]

assessments completed at baseline, monthly to 3 months, then every 2 months up to one year.

Secondary outcome [5]

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]

assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.

Secondary outcome [6]

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]

assessments completed at baseline, monthly to 3 months, then every 2 months up to one year.

Secondary outcome [7]

Changes in fatigue for a large cohort receiving medicinal cannabis.
Assessed with PROMIS Fatigue 13a FACIT-Fat

Timepoint [7]

assessments completed at baseline, 2 weeks (titration), monthly to 3 months, then every 2 months up to one year.

Secondary outcome [8]

Changes in anxiety for a large cohort receiving medicinal cannabis.
Assessed with DASS21;

Timepoint [8]

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?

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]

Commercial sector/Industry

Name [1]

Little Green Pharma Ltd

Address [1]

Suite 2, Level 2, 66 Kings Road, West Perth WA 6005

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

11/08/2020

Approval date [1]

11/11/2020

Ethics approval number [1]

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

Dr Claudia Rutherford

Address

Chris O'Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006 AUSTRALIA

Country

Australia

Phone

+61296271583

Fax

claudia.rutherford@sydney.edu.au

Contact person for public queries

Name

Margaret-Ann Tait

Address

Chris O'Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006 AUSTRALIA

Country

Australia

Phone

+61296271558

Fax

margaret-ann.tait@sydney.edu.au

Contact person for scientific queries

Name

Margaret-Ann Tait

Address

Chris O'Brien Lifehouse (C39Z)
The University of Sydney
NSW 2006 AUSTRALIA

Country

Australia

Phone

+61296271558

Fax

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.

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