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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]

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

Multiple Sclerosis

Epilepsy

Parkinson's Disease

Cancer

Condition category

Condition code

Cancer

Any cancer

Neurological

Epilepsy

Neurological

Parkinson's disease

Neurological

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Changes in health economic outcomes, for a large cohort receiving medicinal cannabis. Assessments are based on the EQ-5D instrument only.

Timepoint [1]

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]

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]

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]

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

Timepoint [3]

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]

Changes in pain for patients accessing medicinal cannabis for Chronic Pain. Assessed with the EQ-5D instrument.

Timepoint [1]

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]

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

Timepoint [2]

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]

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]

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]

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]

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]

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

Timepoint [5]

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]

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]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Curtin University
Ethics Office, Room 108, 
Building 100
Kent St, Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/01/2022

Approval date [1]

09/05/2023

Ethics approval number [1]

Summary

Brief summary

Studies have shown that medicinal cannabis can reduce chronic pain, neuropathic pain, cancer pain, chemotherapy-induced nausea, spasticity in Multiple Sclerosis, and epileptic seizures in patients. However, the true gauge and extent of how medicinal cannabis affects patients in real-life conditions is not fully understood. To gain a better understanding of the real-life impact of medicinal cannabis, the QUEST study (ACTRN12621000063819) assessed the impact of medicinal cannabis on patients’ quality of life, symptoms, and function. This study, named the Global Quest Initiative, aims to expand on the work done by QUEST, with an additional focus on health economics.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older, have been identified as eligible to receive medicinal cannabis, have not started any prescribed medicinal cannabis therapy in the previous 4 weeks, or have commenced medicinal cannabis no more than 2 days ago.

Study details
All participants will be asked to complete a number of questionnaires at the time of commencing medicinal cannabis, and every 1-2 months over a period of 1 year, to measure quality of life, health service use, prescribed medication use, anxiety and depression, fatigue, sleep, pain, work performance, and motor function, depending on the participant’s health indication. The questionnaires will take approximately 1 hour to complete, and will be accessed online via a link emailed to participants. Participants will not receive any treatments or have their treatment altered as part of this study.

It is hoped that this study will show that medicinal cannabis improves quality of life, symptoms, and function in chronic pain sufferers and other patients, and is cost-effective for the treatment of these conditions.

Trial website

https://www.thequestinitiative.com/about/

Trial related presentations / publications

Public notes

Please note, that while this study has a similar name to study ACTRN12621000063819, this is a separate and independent study, based in Perth, WA. 

This is not a follow up on trial ACTRN12621000063819.

Contacts

Principal investigator

Name

Dr Richard Norman

Address

School of Population Health
Curtin University
Kent Street, Bentley
Western Australia, 6102.

Country

Australia

Phone

+61 892661327

Fax

Email

[email protected]

Contact person for public queries

Name

Richard Norman

Address

School of Population Health
Curtin University
Kent Street, Bentley
Western Australia, 6102.

Country

Australia

Phone

+61 892661327

Fax

Email

[email protected]

Contact person for scientific queries

Name

Richard Norman

Address

School of Population Health
Curtin University
Kent Street, Bentley
Western Australia, 6102.

Country

Australia

Phone

+61 892661327

Fax

Email

[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.