None listed
Conditions
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.
Interventions
Sponsors
Eligibility
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
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)