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

University of Manitoba

Status: Enrolling

Conditions: Epilepsy; Neurodevelopmental Disorders; Cancer

Treatments: Drug: Medical Cannabis

Study type: Observational

Funder types: Other

Identifiers

NCT05863910

CAN-RWE

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Epilepsy Cohort

Description:

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

Treatment:

Drug: Medical Cannabis

Cancer Cohort

Description:

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 \[peds-FAACT\]

Treatment:

Drug: Medical Cannabis

General Pediatrics Cohort

Description:

There are no specific outcome scales added for this cohort.

Treatment:

Drug: Medical Cannabis