Palliadelic Treatment to Reduce Psychological Distress in Persons With Inoperable Pancreatobiliary Cancer
Non-randomised, parallel interventional study (n=24) testing a single 25 mg oral psilocybin session with preparatory and integration counselling for distress in persons with inoperable pancreaticobiliary cancer; paired family-member observational arm.
Details
Non-randomised parallel-design pilot evaluating feasibility, safety and preliminary distress outcomes of a single 25 mg oral psilocybin session in persons with stage IV or unresectable gastrointestinal cancers; each patient recruits a paired family member for observational outcomes.
Preparatory sessions (2–4; delivered outpatient or by telehealth) precede one 8-hour monitored psilocybin dosing session; integration sessions (2–3) follow, delivered in clinic or by phone/telehealth.
Primary and secondary outcomes assessed one week post-treatment with exploratory longitudinal measures up to 12 months including patient distress, family member distress and bereavement, healthcare utilisation and choices regarding anti-cancer treatment.