Real World Evidence on the Use of Medical Cannabis in Pediatrics

Study Overview
=================
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.

Official Title
-----------------
Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study

Conditions
-----------------
Cancer, Epilepsy, Neurodevelopmental Disorders

Intervention / Treatment
-----------------
* Drug: Medical Cannabis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epilepsy Cohort<br>For children with epilepsy, the following tools will be added for data collection at each time point: Side effects: Pediatric Epilepsy Side Effects Questionnaire [PESQ] Seizure frequency/severity: Seizure Diary Data Questionnaire | Drug: Medical Cannabis<br>* Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.<br>|
| Cancer Cohort<br>For children with cancer, the following tools will be added for data collection at each time point: Cancer symptom burden: Symptom Screening in Pediatrics Tool [SSPedi] Cachexia: Pediatric Functional Assessment of Anorexia/ Cachexia Treatment [peds-FAACT] | Drug: Medical Cannabis<br>* Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.<br>|
| General Pediatrics Cohort<br>There are no specific outcome scales added for this cohort. | Drug: Medical Cannabis<br>* Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cannabinoids, cannabis, pediatrics