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| Name | Class |
|---|---|
| The Canadian Collaborative for Childhood Cannabinoid Therapeutics | UNKNOWN |
| Canadian Cancer Society (CCS) | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epilepsy Cohort | For children with epilepsy, the following tools will be added for data collection at each time point:
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| Cancer Cohort | For children with cancer, the following tools will be added for data collection at each time point:
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| General Pediatrics Cohort | There are no specific outcome scales added for this cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Cannabis | Drug | Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patterns 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 | baseline to 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in seizure cohort - seizure frequency | Longitudinal assessment for benefit signals in epilepsy seizure frequency/severity measure by a seizure diary | baseline to 24-months |
| Effectiveness in seizure cohort - QOLCE |
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Inclusion Criteria:
Exclusion Criteria:
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Population includes children (3 to 17 years) who are cannabis-naïve or experienced with a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use o medical cannabis primarily for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren E Kelly, PhD | Contact | 2042723149 | lauren.kelly@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sapna Oberoi, MD | University of Manitoba | Principal Investigator |
| Taylor Lougheed, MD | Northern Ontario School of Medicine | Principal Investigator |
| Evan Lewis, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U Manitoba | Recruiting | Winnipeg | Manitoba | R3E0T6 | Canada |
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| Label | URL |
|---|---|
| For more information on our research team visit our website. | View source |
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summary level data will be available upon reasonable request with appropriate approval and oversight of a research ethics board.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004827 | Epilepsy |
| D065886 | Neurodevelopmental Disorders |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064086 | Medical Marijuana |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE
| 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 | baseline to 24-months |
| Effectiveness in oncology cohort - cachexia | Longitudinal assessment of cachexia using Peds-FAACT | 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 | baseline to 24-months |
| Family related quality of life | Longitudinal assessment of cachexia using PedsQL | baseline to 24-months |
| Changes in mood - anxiety | PROMIS short form scales for pediatric anxiety symptoms 8a v2.0 | baseline to 24-months |
| Changes in mood - depression | PROMIS short form scales for pediatric depression symptoms 8a v2.0 | baseline to 24-months |
| Changes in mood - positive affect | PROMIS short form pediatric positive affect scale 8a v2.0 | baseline to 24-months |
| Changes in sleep related impairment | PROMIS short form pediatric sleep related impairment scale 8a v2.0 | baseline to 24-months |
| Changes in pain interference | PROMIS short form pediatric pain interference scale 8a v2.0 | 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. | baseline-24months |
| Neurology Centre of Toronto |
| Principal Investigator |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |