CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.
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.
Study Type
OBSERVATIONAL
Enrollment
500
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
U Manitoba
Winnipeg, Manitoba, Canada
RECRUITINGPatterns of cannabis use (caregiver-reported)
Describe patterns of cannabis use are described using a standard data collection form including dose and product type completed by caregivers at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months
Time frame: baseline to 24-months
Effectiveness in seizure cohort - seizure frequency
Longitudinal assessment for benefit signals in epilepsy seizure frequency/severity measure by a seizure diary
Time frame: baseline to 24-months
Effectiveness in seizure cohort - QOLCE
Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE
Time frame: baseline to 24-months
Effectiveness in oncology cohort - symptom burden
Longitudinal assessment for benefit signals in caregiver reported changes in symptom burden assessed using mini-SSPEDI (under 8 yr) and SSPEDI scales
Time frame: baseline to 24-months
Effectiveness in oncology cohort - cachexia
Longitudinal assessment of cachexia using Peds-FAACT
Time frame: baseline to 24-months
Adverse events
Cannabis-related adverse events and serious adverse events reported by caregivers using a standard AE data collection tool and categorized according to CTCAE v5.0 at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months
Time frame: baseline to 24-months
Family related quality of life
Longitudinal assessment of cachexia using PedsQL
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Time frame: baseline to 24-months
Changes in mood - anxiety
PROMIS short form scales for pediatric anxiety symptoms 8a v2.0
Time frame: baseline to 24-months
Changes in mood - depression
PROMIS short form scales for pediatric depression symptoms 8a v2.0
Time frame: baseline to 24-months
Changes in mood - positive affect
PROMIS short form pediatric positive affect scale 8a v2.0
Time frame: baseline to 24-months
Changes in sleep related impairment
PROMIS short form pediatric sleep related impairment scale 8a v2.0
Time frame: baseline to 24-months
Changes in pain interference
PROMIS short form pediatric pain interference scale 8a v2.0
Time frame: baseline to 24-months
Parental overall impression of behaviour
Parents/Caregivers will be asked to report on if their childs behaviour has improved or worsened and will have an open-ended text box to describe anything they want to tell us about changes in their child's behaviour.
Time frame: baseline-24months