Real World Evidence on the Use of Medical Cannabis in Pediatrics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Cannabis.
- Who it may be relevant to
- Registry conditions: Cancer, Epilepsy, Neurodevelopmental Disorders. Basic parameters: 3 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study
Overview
CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.
Detailed description
Pediatric patients (3 to 17 years) using medical cannabis (MC) for pain, sleep, mood, behaviour, seizures, treatment of cancer, or to manage symptoms related to cancer or cancer-treatment are eligible to join this 24-month study if they have a valid MC authorization.
Following screening, eligible participants will be contacted by the study coordinator. Following informed consent, study participants will record complete outcome measures on pain, sleep, mood (anxiety, depression and positive affect), behaviour, as well as report their cannabis use and indication-specific outcomes as applicable at 3, 6, 12, and 18 weeks, as well as 6, 12, 18 and 24-months.
Interventions
- Drug Medical Cannabis
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
Primary outcome measures
- Patterns of cannabis use (caregiver-reported) [Time frame: baseline to 24-months]
Secondary outcome measures (12)
- Effectiveness in seizure cohort - seizure frequency [Time frame: baseline to 24-months]
- Effectiveness in seizure cohort - QOLCE [Time frame: baseline to 24-months]
- Effectiveness in oncology cohort - symptom burden [Time frame: baseline to 24-months]
- Effectiveness in oncology cohort - cachexia [Time frame: baseline to 24-months]
- Adverse events [Time frame: baseline to 24-months]
- Family related quality of life [Time frame: baseline to 24-months]
- Changes in mood - anxiety [Time frame: baseline to 24-months]
- Changes in mood - depression [Time frame: baseline to 24-months]
- Changes in mood - positive affect [Time frame: baseline to 24-months]
- Changes in sleep related impairment [Time frame: baseline to 24-months]
- Changes in pain interference [Time frame: baseline to 24-months]
- Parental overall impression of behaviour [Time frame: baseline-24months]
Eligibility criteria
Inclusion criteria
- 3 to 17 years
- have a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use of medical cannabis
- medical cannabis is authorized for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management
- ability to respond to electronic questionnaires in English
Exclusion criteria
- individuals using cannabis for medical purposes without a medical cannabis authorization from a health care provider
- those only using cannabis recreationally
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- U Manitoba — Winnipeg
Identifiers
NCT: NCT05863910 · CAN-RWE