The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial. Participants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial.
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Study participant recruitment completion time, calculated as the time required to reach a sample size of 10.
Timeframe: From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.
Participant withdrawal rate, calculated as the number of participants who withdraw from the trial as a proportion of the total number of participants randomized.
Timeframe: Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)
Study medication tolerability, as indicated by the proportion of participants who tolerate the protocol dosing schedule.
Timeframe: Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)
Participant adherence to the study medication dosing schedule, calculated as the proportion of participants who demonstrate acceptable medication compliance.
Timeframe: Day 58 (date of end of treatment)
Study visit attendance, calculated as the proportion of visits completed across the study sample.
Timeframe: Screening to day 43 (date of the end of the maintenance dosing period clinic visit)
Blood test completion, calculated as the proportion of blood tests completed across the study sample.
Timeframe: Screening to day 43 (date of the end of the maintenance dosing period clinic visit)
Parent questionnaire completion, calculated as the proportion of parent-report questionnaires completed across the study sample.
Timeframe: Screening to day 86 (participant trial completion)
Self-report questionnaire completion, calculated as the proportion of adolescent self-report questionnaires completed across the study sample.
Timeframe: Screening to day 86 (participant trial completion)
Study design acceptability will be evaluated through a parent-completed study specific evaluation questionnaire completed at the end of the study.
Timeframe: Day 86 (participant trial completion)