Real World Evidence on the Use of Medical Cannabis in Pediatrics (CAN-RWE)

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

CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Cancer; Neurodevelopmental Disorders
• Intervention / Treatment: Drug: Medical Cannabis

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Lauren E Kelly, PhD; Phone Number: 2042723149; Email: lauren.kelly@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E0T6
      • Recruiting
      • U Manitoba
      • Contact: Lauren Kelly, PhD; Phone Number: 2042723149; Email: lauren.kelly@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epilepsy Cohort; 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; Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
Cancer Cohort; 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; Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
General Pediatrics Cohort; There are no specific outcome scales added for this cohort.	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.

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Cancer Society (CCS); The Canadian Collaborative for Childhood Cannabinoid Therapeutics
• Investigators: Principal Investigator: Sapna Oberoi, MD, University of Manitoba; Principal Investigator: Taylor Lougheed, MD, Northern Ontario School of Medicine; Principal Investigator: Evan Lewis, MD, Neurology Centre of Toronto

Publications and helpful links

Helpful Links

• For more information on our research team visit our website.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; cannabis; cannabinoids
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: CAN-RWE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: summary level data will be available upon reasonable request with appropriate approval and oversight of a research ethics board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No