CAN-PACT PILOT STUDY
What is PAT-MIND?
PAT-MIND is the formal name of the CAN-PACT pilot study, one of the research initiatives being conducted through the Canadian Network for Psychedelic-Assisted Cancer Therapy (CAN-PACT).
The full study title is:
High vs. Low-Dose Group-Based Psilocybin-Assisted Therapy (PAT) with or without Mindfulness-Based (MB) Preparation and Integration for Demoralization in Adults with Advanced Cancer (PAT-MIND): A Pilot Feasibility 2x2 Factorial Multisite Trial
In simpler terms, PAT-MIND is studying group-based psilocybin-assisted therapy for adults with advanced cancer experiencing demoralization. It compares higher and lower doses of psilocybin, alongside mindfulness-based and standard supportive approaches to preparation and integration.
The study uses a combination of virtual and in-person group therapy across two pilot sites. What researchers learn through PAT-MIND will help CAN-PACT refine how this approach is delivered and inform the design of a larger multisite clinical trial.
Purpose
While research into psilocybin-assisted therapy is growing, there is still limited evidence specific to people living with advanced cancer.
PAT-MIND aims to help address this gap by building knowledge about the safety, feasibility, and delivery of psilocybin-assisted therapy for people with advanced cancer experiencing demoralization. The study will also help researchers better understand participants’ experiences and identify areas that may need to be refined.
This research can help determine how psilocybin-assisted therapy may be studied more effectively and appropriately within cancer care. It can also provide important information to guide future research in this emerging area.
As a pilot study, the findings will help inform the design of larger future studies and contribute to a better understanding of the potential role of psilocybin-assisted therapy in cancer care.
Objectives
PAT-MIND aims to:
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Assess the feasibility and safety of delivering group-based psilocybin-assisted therapy to adults with advanced cancer experiencing demoralization.
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Compare higher and lower doses of psilocybin within the study.
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Compare standard and mindfulness-based approaches to preparation and integration.
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Explore participants’ experiences with the different approaches.
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Gather information to help refine the program and inform future, larger studies of psilocybin-assisted therapy in cancer care.
Study Process
1. Screening & Consent
Learn about the study, complete screening, and provide consent.
2. Study Onboarding
Complete initial study activities and be assigned to one of four study groups.
3. Preparation
Attend individual and group preparation sessions.
4. Dosing Day
Take part in one supported, in-person psilocybin session.
5. Integration
Attend individual and group integration sessions.
6. Follow-Up
Complete follow-up questionnaires and, for some participants, optional interviews.
Eligibility
You may be eligible to participate in PAT-MIND if you:
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Are 18 years of age or older
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Have advanced cancer
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Are experiencing demoralization
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Are able to attend and participate in study activities
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Are able to communicate in English
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Are not pregnant or lactating
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Have a responsible adult who can pick you up after the psilocybin dosing session and provide support afterward
What You May Want to Know
Have questions about participating in the CAN-PACT pilot study? Find quick answers to some of the most common questions about PAT-MIND, from getting started to what happens during and after the study.
Looking for more? A specific question? Visit the full FAQ page for more detailed information and answers to additional questions.
What is Demoralization?
Demoralization is a term used in healthcare to describe a specific type of emotional distress that can happen when facing a serious or advanced illness like cancer. It is characterized by feelings of hopelessness, a loss of purpose or meaning in daily life, feeling trapped, and a sense that your usual coping strategies are no longer working. Unlike general sadness, demoralization specifically affects your sense of hope, identity, and dignity. It is a completely understandable human response to severe illness, not a personal weakness or a sign that you have given up.
How is Demoralization Different From Depression, Anxiety, Grief, or Normal Cancer Distress?
It is common to confuse demoralization with depression, anxiety, or grief, but medical experts recognize important differences. Depression usually involves a general loss of the ability to experience pleasure (called anhedonia), severe self-criticism, and slowed thinking. In contrast, people experiencing demoralization can still enjoy pleasant moments with loved ones, but they struggle with a deep loss of hope, purpose, and direction regarding their future with cancer. Grief is a natural response to specific losses, whereas demoralization reflects feeling unable to cope with ongoing uncertainty. Identifying demoralization helps us offer therapies specifically designed to restore meaning and agency.
Which Visits are in Person and Which can be Attended Virtually from Home?
To reduce travel burden for people living with advanced cancer, PAT-MIND uses a 'hybrid' delivery model. In-person attendance is mandatory for Step 3 screening (physical exam) and Visit 4 (Dosing Day) at the hospital clinic. However, preparation sessions (Visits 1-3) and integration sessions (Visits 5-7) can be attended virtually via secure video call from the comfort of your home, provided you have reliable internet and a private space.
Are Travel, Parking, or Meal Expenses Reimbursed for In-Person Visits?
Yes. Participating in PAT-MIND should not create a financial burden for you or your family. Reasonable travel expenses-including hospital parking fees for in-person clinic visits-are covered by the study in addition to per-visit compensation. On the full 8-hour dosing day, meals and refreshments are provided for you at the clinic facility. Reimbursement forms and parking passes are provided directly by our research coordinators.
What is Psychedelic-Assisted Therapy (PAT)?
Psychedelic-assisted therapy (PAT) is a specialized clinical approach that combines the controlled medical administration of a psychedelic substance (in this study, pharmaceutical psilocybin) with structured psychological support. PAT is not just about taking a pill; the drug is used as a catalyst within a broader 7-visit therapeutic process. This process includes individual and group preparation sessions to build trust and safety, professional medical supervision during the dosing day, and post-dosing integration sessions to help you make sense of your experience and apply insights to your life with cancer.
Is Clinical Psilocybin the Same as Recreational 'Magic Mushrooms'?
No, clinical psilocybin used in PAT-MIND is very different from recreational 'magic mushrooms.' Recreational use often involves unknown dosages, variable wild mushroom species, unpredictable settings, and lack of safety monitoring. In contrast, PAT-MIND uses PEX010-a pure, pharmaceutical-grade capsule with an exact dose approved by Health Canada. Furthermore, the session takes place in a quiet, comfortable medical facility with two trained healthcare facilitators present at all times, accompanied by precise medical monitoring and structured psychological preparation and integration.
Will I Hallucinate or Lose Touch with Reality?
During a psilocybin session, you may experience changes in perception, but full 'hallucinations' where you completely lose touch with reality are rare in a supportive medical setting. Most participants experience heightened visual imagery when wearing eyeshades, such as seeing flowing colors, geometric patterns, or dream-like scenes in their mind's eye. With eyes open, everyday objects or lighting may appear warmer or slightly altered. Importantly, you retain an 'observer mind'-meaning you remain aware that you are a participant in a clinic room and that the effects are temporary and caused by the medication.
What Physical Risks or Side Effects are Possible with Psilocybin?
Psilocybin has a well-established physical safety profile in medical research. Common physical side effects during or immediately after the session are typically mild, temporary, and resolve naturally within 24 hours. These include: mild headache, temporary nausea or stomach upset, slight dizziness, dilated pupils, muscle tightness, and temporary increases in blood pressure and heart rate. Severe physical reactions are extremely rare. On dosing day, your vital signs are monitored closely, and medication is available to manage physical discomfort if needed.
Will Psilocybin Interact with my Current Cancer Treatments or Pain Medications?
Safety is our highest priority. Psilocybin is generally compatible with standard cancer treatments like chemotherapy, immunotherapy, targeted therapy, and radiation, as well as most common pain medications. However, certain psychiatric medications (such as SSRI antidepressants) or medications that affect serotonin require careful medical evaluation because they can blunt or alter psilocybin's effects. During screening, our study physicians complete a thorough review of your full medication list to ensure there are no unsafe drug interactions before you are approved to participate.
What if I Take an Antidepressant or Other Psychiatric Medication?
If you take an antidepressant (such as an SSRI, SNRI, or other psychiatric medication), you may still be considered for the trial. However, certain antidepressants bind to the same serotonin receptors in the brain as psilocybin. This can either blunt (reduce) psilocybin's emotional effects or, in rare cases, cause an unwanted reaction. During screening, our study physicians review your exact drug, dosage, and medical history to determine whether you can participate safely as you are, or if a supervised medication taper is appropriate.
What Happens During the Dosing Day and How Long Does it Last?
Dosing day (Visit 4) is an approximately 8-hour spent at the hospital clinical facility. You arrive in the morning, complete a physical check (vitals and health review), and meet your facilitators and group cohort. You take a single oral psilocybin capsule with water. You then rest comfortably in a recliner bed wearing eyeshades and listening to a curated music playlist through headphones. Two lead facilitators and a study doctor remain in the room throughout the entire 6 to 8-hour session. Afterward, you receive a light meal, a medical check, and are discharged home with your designated caregiver.
What Medical Staff and Emergency Support are Present During the Dosing Day?
Your medical safety on dosing day is maintained by a multi-layered healthcare team. Present in the group room throughout the entire session are at least two registered lead facilitators (such as oncology nurses, social workers, or psychologists) and two trainee facilitators. In addition, an on-site Qualified Investigator (study physician) is physically present in the clinic facility at all times, administer rescue medications if necessary, or manage any medical emergency.
Who do I Contact if I Experience Emotional Distress or Questions After Returning Home?
Your safety support continues long after you leave the hospital. Before being discharged on dosing day, you will be given a wallet card containing emergency contact details, including a 24/7 study crisis phone number answered directly by our clinical research team. If you experience distressing emotions, severe anxiety, trouble sleeping, or medical concerns after returning home, you can call this number at any time for immediate clinical guidance, supportive counseling, or emergency coordination.
Can I Withdraw from the Study at Any Time Without Giving a Reason?
Yes. You can choose to withdraw from the PAT-MIND study at any point during the trial-whether before preparation begins, after a prep session, on dosing day, or during integration. You do not need to provide a justification or reason for leaving. Simply inform any member of the study team. Withdrawing will not cause any penalty, prejudice, or change in your regular cancer treatments or palliative care. If you withdraw, you can also decide whether or not you consent to let the team use data collected up to that point.
AM I ELIGIBLE?
Interested in participating in the CAN-PACT pilot study? You may be eligible for PAT-MIND if you:
18 years of age or older
Have advanced cancer
Are able to communicate in English
Are not pregnant or lactating
Are experiencing demoralization
Are able to attend and participate in study activities
Have a responsible adult who can pick you up after
Meeting this criteria does not automatically mean you are eligible to participate. The study team will complete a screening process to determine whether PAT-MIND is appropriate for you.