Cancer, Epilepsy, Neurodevelopmental Disorders
Conditions
Keywords
cannabinoids, cannabis, pediatrics
Brief summary
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
DRUGMedical Cannabis
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
Sponsors
The Canadian Collaborative for Childhood Cannabinoid Therapeutics
Canadian Cancer Society (CCS)
Canadian Institutes of Health Research (CIHR)
University of Manitoba
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patterns of cannabis use (caregiver-reported) | baseline to 24-months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness in seizure cohort - QOLCE | baseline to 24-months | Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE |
| Effectiveness in oncology cohort - symptom burden | baseline to 24-months | Longitudinal assessment for benefit signals in caregiver reported changes in symptom burden assessed using mini-SSPEDI (under 8 yr) and SSPEDI scales |
| Effectiveness in oncology cohort - cachexia | baseline to 24-months | Longitudinal assessment of cachexia using Peds-FAACT |
| Adverse events | baseline to 24-months | 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 |
| Family related quality of life | baseline to 24-months | Longitudinal assessment of cachexia using PedsQL |
| Effectiveness in seizure cohort - seizure frequency | baseline to 24-months | Longitudinal assessment for benefit signals in epilepsy seizure frequency/severity measure by a seizure diary |
| Changes in mood - depression | baseline to 24-months | PROMIS short form scales for pediatric depression symptoms 8a v2.0 |
| Changes in mood - positive affect | baseline to 24-months | PROMIS short form pediatric positive affect scale 8a v2.0 |
| Changes in sleep related impairment | baseline to 24-months | PROMIS short form pediatric sleep related impairment scale 8a v2.0 |
| Changes in pain interference | baseline to 24-months | PROMIS short form pediatric pain interference scale 8a v2.0 |
| Parental overall impression of behaviour | baseline-24months | 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. |
| Changes in mood - anxiety | baseline to 24-months | PROMIS short form scales for pediatric anxiety symptoms 8a v2.0 |
Countries
Canada
Contacts
Primary ContactLauren E Kelly, PhD
Outcome results
None listed