Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Patterns of cannabis use (caregiver-reported)
研究概览
简要总结
CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •individuals using cannabis for medical purposes without a medical cannabis authorization from a health care provider
- •those only using cannabis recreationally
研究组 & 干预措施
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
干预措施: Medical Cannabis (Drug)
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]
干预措施: Medical Cannabis (Drug)
General Pediatrics Cohort
There are no specific outcome scales added for this cohort.
干预措施: Medical Cannabis (Drug)
结局指标
主要结局
Patterns of cannabis use (caregiver-reported)
时间窗: 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
次要结局
- Adverse events(baseline to 24-months)
- Changes in mood - positive affect(baseline to 24-months)
- Family related quality of life(baseline to 24-months)
- Changes in sleep related impairment(baseline to 24-months)
- Changes in mood - anxiety(baseline to 24-months)
- Changes in pain interference(baseline to 24-months)
- Parental overall impression of behaviour(baseline-24months)
- Effectiveness in seizure cohort - seizure frequency(baseline to 24-months)
- Effectiveness in oncology cohort - symptom burden(baseline to 24-months)
- Effectiveness in oncology cohort - cachexia(baseline to 24-months)
- Changes in mood - depression(baseline to 24-months)
- Effectiveness in seizure cohort - QOLCE(baseline to 24-months)