Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)

Conditions studied

Pain, Sleep, Anxiety, Depression, Epilepsy

About this study

This prospective observational study aims to describe the effectiveness of MC on pain, epilepsy, sleep and /or anxiety/depression in a cohorts of patients authorized to use MC, using pre-defined, validated self assessment scales.

Interventions

• Other: Medical Cannabis — Verified medical cannabis products available within the current real-world study conform to Health Canada testing requirements

Primary outcomes

• Change in pain intensity from baseline to week 24 post-authorization of MC: Measured using the numerical rating scale (NRS). (Baseline, 6, 12, 18 (if applicable) and 24 weeks)
• Change in pain interference from baseline to week 24 post-authorization of MC: Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference short form 6a. (Baseline, 6, 12, 18 (if applicable) and 24 weeks)
• Sleep: Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to week 24 post-authorization of MC (Baseline, 6, 12, 18 (if applicable) and 24 weeks)
• Anxiety: Change in the symptoms from baseline to week 24 post-authorization of MC; Measured using Generalized Anxiety Disorder 7-item scale (GAD-7). (Baseline, 6, 12, 18 (if applicable) and 24 weeks)
• Depression: Change in the symptoms from baseline to week 24 post-authorization of MC. Measured by Patient Health Questionnaire 9 item scale (PHQ-9). (Baseline, 6, 12, 18 (if applicable) and 24 weeks)
• Change in quality of life from baseline to Week 24: Measured using EuroQuol-5D-3-level health questionnaires(EQ-5D-3L) assessment scale. (Baseline, 6, 12, 18 (if applicable) and 24 weeks)
• Epilepsy: change in seizure frequency for multiple different seizure types from baseline to Week 24 (Baseline, 6, 12, 18 and 24 weeks)

Eligibility information

Study locations

• Toronto General Hospital, UHN, Toronto, Ontario M5G 2C4 Canada