Real World Evidence on the Use of Medical Cannabis in Pediatrics
- Registration Number
- NCT05863910
- Lead Sponsor
- University of Manitoba
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- individuals using cannabis for medical purposes without a medical cannabis authorization from a health care provider
- those only using cannabis recreationally
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Epilepsy Cohort Medical Cannabis 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 Cancer Cohort Medical Cannabis 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 \[peds-FAACT\] General Pediatrics Cohort Medical Cannabis There are no specific outcome scales added for this cohort.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Changes in mood - positive affect baseline to 24-months PROMIS short form pediatric positive affect scale 8a v2.0
Family related quality of life baseline to 24-months Longitudinal assessment of cachexia using PedsQL
Changes in sleep related impairment baseline to 24-months PROMIS short form pediatric sleep related impairment scale 8a v2.0
Changes in mood - anxiety baseline to 24-months PROMIS short form scales for pediatric anxiety symptoms 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.
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
Changes in mood - depression baseline to 24-months PROMIS short form scales for pediatric depression symptoms 8a v2.0
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
Effectiveness in seizure cohort - QOLCE baseline to 24-months Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE
Trial Locations
- Locations (1)
U Manitoba
🇨🇦Winnipeg, Manitoba, Canada