Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Pati… (NCT07048743) | Clinical Trial Compass
RecruitingPhase 2
Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer
Canada15 participantsStarted 2025-07-16
Plain-language summary
The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older.
* Participant must reside in Ontario, Canada.
* Ability to speak and read English (participant to provide written informed consent and participate in PEARL intervention, as determined by study personnel).
* No cognitive impairment indicated in medical record or by the primary care physician.
* Primary or significant caregiver of a patient with advanced cancer enrolled in a companion trial of PEARL for patients with advanced cancer or caregiver of a patient receiving psilocybin-therapy through the Special Access Program (SAP) at University Health Network (UHN); such patients will have been recruited from psychosocial oncology or palliative care clinics at Princess Margaret (study physicians to assess appropriateness of inclusion and whether treatment will support the family system).
* At least mild anxiety or depression symptoms, defined as a score of \>5 on the General Anxiety Disorder-7 (GAD-7) or \>8 on the Patient Health Questionnaire-9 (PHQ-9).
* Interest in and ability to participate in and complete the PEARL intervention and protocol as outlined.
* Normal hepatic functioning as determined by prior medical history or/and screening bloodwork (international normalized ratio \[INR\]\<1.5, aspartate aminotransferase \[AST\]/alanine transaminase \[ALT\] \< 2x upper limit of normal, normal range bilirubin, platelets ≥150).
* Normal renal functioning as determined by prior medical history or/and screening bloodwork (estimated glo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment feasibility as assessed by the number of caregivers who consent/number of caregivers who meet eligibility criteria.
Timeframe: 30 months
2
Retention feasibility as assessed by the number of caregivers completing primary endpoint measures/number of caregivers consented.
Timeframe: 30 months
3
Adherence feasibility as assessed by the number of caregivers completing all PEARL sessions/number of caregivers consented.
Timeframe: 30 months
4
Acceptability of PEARL therapy from the perspective of the caregivers of patients with advanced cancer obtained through qualitative interviews.