Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000583640
Ethics application status
Approved
Date submitted
17/11/2022
Date registered
29/05/2023
Date last updated
21/05/2024
Date data sharing statement initially provided
29/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Global QUEST initiative: QUality of life Evaluation STudy:
Assessing Health Related Quality of Life in patients receiving medicinal cannabis.
Scientific title
The QUEST Global initiative: QUality of life Evaluation STudy: Assessing Health Related Quality of Life in patients receiving medicinal cannabis.
Secondary ID [1] 307817 0
Nil
Universal Trial Number (UTN)
Trial acronym
The Global Quest Initiative
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 327410 0
Multiple Sclerosis 327411 0
Epilepsy 327412 0
Parkinson's Disease 327413 0
Cancer 327414 0
Condition category
Condition code
Cancer 324540 324540 0 0
Any cancer
Neurological 324541 324541 0 0
Epilepsy
Neurological 324542 324542 0 0
Parkinson's disease
Neurological 324543 324543 0 0
Multiple sclerosis

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 health economic relevant outcomes and patient-reported outcomes in patients with chronic conditions, who are 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.
The validated questionnaires we will use include EQ-5D, DASS21, HPQ-AP, and Health Service Utilisation (HERU). Each questionnaire should take less than 15 minutes to answer and participants will self-complete questionnaires through an online platform at home, accessible on a computer or other device with internet connection. Surveys will be completed at baseline before starting medicinal cannabis, at 2-3 weeks (end of titration period), and then at 1-, 3-, 6-, 9-, and 12-months post-titration period, and then at six month periods for the duration of a participant’s involvement with the study.
Intervention code [1] 324285 0
Not applicable
Comparator / control treatment

No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332363 0
Changes in health economic outcomes, for a large cohort receiving medicinal cannabis. Assessments are based on the EQ-5D instrument only.
Timepoint [1] 332363 0
Assessments will follow the schedule below:
Baseline (Before commencement of treatment).
Tritation, two weeks after first treatment,
One month after treatment.
Three months after treatment.
Six months after treatment.
Nine months after treatment.
Twelve months after treatment.
Primary outcome [2] 332364 0
Changes in health-related quality of life, for a large cohort receiving medicinal cannabis. Assessments are based on the EQ-5D instrument only.
Timepoint [2] 332364 0
Assessments will follow the schedule below:
Baseline (Before commencement of treatment).
Tritation, two weeks after first treatment,
One month after treatment.
Three months after treatment.
Six months after treatment.
Nine months after treatment.
Twelve months after treatment.
Primary outcome [3] 332365 0
Changes in depression for a large cohort receiving medicinal cannabis. Assessed with the DASS21 instrument.
Timepoint [3] 332365 0
Assessments will follow the schedule below:
Baseline (Before commencement of treatment).
Tritation, two weeks after first treatment,
One month after treatment.
Three months after treatment.
Six months after treatment.
Nine months after treatment.
Twelve months after treatment.
Secondary outcome [1] 413196 0
Changes in pain for patients accessing medicinal cannabis for Chronic Pain. Assessed with the EQ-5D instrument.
Timepoint [1] 413196 0
Assessments will follow the schedule below:
Baseline (Before commencement of treatment).
Tritation, two weeks after first treatment,
One month after treatment.
Three months after treatment.
Six months after treatment.
Nine months after treatment.
Twelve months after treatment.
Secondary outcome [2] 413198 0
Healthcare resource use assessed with study specific questionnaire adapted from the 'annotated cost questionnaire for completion by patients' HERU Discussion Paper.
Timepoint [2] 413198 0
Assessments will follow the schedule below:
Baseline (Before commencement of treatment).
Tritation, two weeks after first treatment,
One month after treatment.
Three months after treatment.
Six months after treatment.
Nine months after treatment.
Twelve months after treatment.
Secondary outcome [3] 413199 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 [3] 413199 0
Assessments will follow the schedule below:
Baseline (Before commencement of treatment).
Tritation, two weeks after first treatment,
One month after treatment.
Three months after treatment.
Six months after treatment.
Nine months after treatment.
Twelve months after treatment.
Secondary outcome [4] 413201 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 [4] 413201 0
Assessments will follow the schedule below:
Baseline (Before commencement of treatment).
Tritation, two weeks after first treatment,
One month after treatment.
Three months after treatment.
Six months after treatment.
Nine months after treatment.
Twelve months after treatment.
Secondary outcome [5] 413203 0
Changes in anxiety for a large cohort receiving medicinal cannabis. Assessed with DASS21;
Timepoint [5] 413203 0
Assessments will follow the schedule below:
Baseline (Before commencement of treatment).
Tritation, two weeks after first treatment,
One month after treatment.
Three months after treatment.
Six months after treatment.
Nine months after treatment.
Twelve months after treatment.

Eligibility
Key inclusion criteria
All of the following must be satisfied for enrollment in the study:
• adult patients (aged 18 years)
• patient has been identified as eligible to receive medicinal cannabis by a TGA approved Authorised Prescriber or via the Special Access Scheme (SAS-B) and the doctor has sought and obtained TGA approval for Little Green Pharma (LGP) products for their patient.
• patient is able to read and understand English
• patient is able to provide informed consent
• patient has not started any prescribed medicinal cannabis therapy in the previous 4 weeks; or started prescribed LGP medicinal cannabis therapy within the previous 2 days (we expect no therapeutic benefit within 2 days) and has not received any prescribed medicinal cannabis therapy in the previous 4 weeks
• patient has a life expectancy of more than 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 or breastfeeding
• are unable to speak, read and/or write in English
• are denied access to medicinal cannabis under the relevant Special Access Scheme (SAS) for their country of registration
• are unable to provide informed consent
• are already receiving prescribed 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
All analyses will be carried out using STATA v16. Baseline demographic and clinical data will be summarized descriptively for all patients registered for the study (and by subgroups of health conditions, where possible). Categorical data will be presented as frequencies and percentages. For continuous scale data, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum will be presented. The baseline and follow-up scores of each PROs will also be summarized descriptively as above, and where possible, by subgroups of interest. Statistical analyses will be conducted on a prespecified quarterly basis. Immediate changes in the health economic outcomes as well as PROs will be assessed using paired samples t-test or non-parametric tests. Associations between demographic, clinical data and changes in longitudinal health economic outcomes as well as PROs will be analysed using regression methods adjusted for covariates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
17/06/2023
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12000
Accrual to date
1100
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312086 0
Commercial sector/Industry
Name [1] 312086 0
Little Green Pharma Ltd
Country [1] 312086 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] 313606 0
None
Name [1] 313606 0
Address [1] 313606 0
Country [1] 313606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311494 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 311494 0
Ethics committee country [1] 311494 0
Australia
Date submitted for ethics approval [1] 311494 0
04/01/2022
Approval date [1] 311494 0
09/05/2023
Ethics approval number [1] 311494 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121298 0
Dr Richard Norman
Address 121298 0
School of Population Health
Curtin University
Kent Street, Bentley
Western Australia, 6102.
Country 121298 0
Australia
Phone 121298 0
+61 892661327
Fax 121298 0
Email 121298 0
[email protected]
Contact person for public queries
Name 121299 0
Richard Norman
Address 121299 0
School of Population Health
Curtin University
Kent Street, Bentley
Western Australia, 6102.
Country 121299 0
Australia
Phone 121299 0
+61 892661327
Fax 121299 0
Email 121299 0
[email protected]
Contact person for scientific queries
Name 121300 0
Richard Norman
Address 121300 0
School of Population Health
Curtin University
Kent Street, Bentley
Western Australia, 6102.
Country 121300 0
Australia
Phone 121300 0
+61 892661327
Fax 121300 0
Email 121300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.