PAT-MIND FAQ | CAN-PACT

PAT-MIND
Frequently Asked Questions

How to Use This Page

Have questions about the CAN-PACT pilot study? This page is organized around where you may be in your study journey — or simply what you’re most curious about.

Each section focuses on a different stage or topic. Within each section, you’ll find tabs that group related questions together, making it easier to find the information that matters to you.

Use the directory below to jump directly to a section, or explore the page at your own pace.

LEARNING ABOUT THE STUDY

GETTING STARTED

PREPARING FOR DOSING DAY

DOSING DAY

AFTER DOSING DAY

AFTER THE STUDY

GENERAL QUESTIONS ABOUT THE STUDY

Learning About the Study

Are you just starting to learn about psilocybin-assisted therapy or curious about the CAN-PACT pilot study? This is a great place to start. Explore some of the most common questions about the study and what participation involves.

Understanding Demoralization

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.

Why is Demoralization Important to Identify in Cancer Care?

Identifying demoralization is essential because standard psychiatric treatments, such as traditional antidepressant medications, often do not fully relieve existential distress or loss of meaning. When demoralization goes unrecognized, patients may suffer in silence or receive treatments that do not address the root of their emotional pain. Recognizing demoralization allows your healthcare team to offer tailored interventions-such as mindfulness practices, group support, and psychedelic-assisted therapy-that are specifically designed to help rebuild a sense of purpose, dignity, and connection during advanced cancer care.

Does Having Demoralization Mean I am Mentally Ill?

No, experiencing demoralization does not mean you have a psychiatric disorder or mental illness. Healthcare professionals understand demoralization as a natural, human reaction to the profound physical, emotional, and practical challenges of living with advanced cancer. Facing a serious diagnosis can disrupt your daily roles, relationships, independence, and future plans, making it hard to maintain hope. Participating in research focused on demoralization is about finding tools to support your emotional resilience and spiritual well-being, not labeling you with a mental illness.

Why does PAT-MIND Focus Specifically on Demoralization Rather than General Depression?

The PAT-MIND study focuses specifically on demoralization because recent scientific research suggests that psilocybin-assisted therapy and mindfulness training work together to increase psychological flexibility and openness. While standard depression treatments often focus on chemical imbalances, demoralization stems from a loss of meaning, agency, and spiritual connection-areas where psilocybin and mindfulness have shown unique promise. By focusing on demoralization in advanced cancer, PAT-MIND aims to pioneer a treatment that directly restores hope, connection, and peace of mind when standard options fall short.

PAT & PSILOCYBIN

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.

What is Psilocybin and Where Does it Come From?

Psilocybin is a naturally occurring compound historically found in certain species of mushrooms, which have been used for centuries in traditional Indigenous healing practices. In the PAT-MIND trial, we use a standardized, pure pharmaceutical formulation called PEX010, manufactured under strict Health Canada regulatory guidelines. It is given as an oral capsule with exact, tested dosing. Psilocybin temporarily alters brain network connectivity-particularly softening rigid patterns of thought-allowing new perspectives, deep emotions, and a altered sense of awareness to emerge in a safe clinical setting.

How do Psilocybin and Psychological Support Work Together?

Psilocybin and psychological support work together in a synergistic, two-part process. Scientists describe psilocybin as creating a temporary 'neuroplasticity window'-a period where the brain's habitual, rigid thought patterns (like continuous worrying or feeling stuck) are temporarily relaxed. The psychological support sessions provide the safe 'container' before, during, and after this window. Preparation helps you feel grounded and set calm intentions, dosing supervision ensures complete physical and emotional safety, and integration helps you translate temporary insights into lasting emotional peace and coping skills.

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.

Is Psilocybin Legal in the Clinical Trial?

Yes, psilocybin is completely legal within the formal context of the PAT-MIND clinical trial. While psilocybin is normally a controlled substance in Canada, Health Canada has granted a formal Clinical Trial Authorization (CTA) and site-specific controlled substance exemptions for this research study. The trial is also reviewed and monitored by institutional Research Ethics Boards (REBs) at the University of Calgary and Queen's University. Participating in this study is legally protected and conducted under strict federal safety regulations.

Is PAT in this Trial the Same as 'Microdosing'?

No, PAT-MIND does not involve 'microdosing.' Microdosing refers to taking tiny, sub-perceptual amounts of psychedelics (often 1% to 5% of a full dose) every few days while continuing ordinary daily activities, without therapy. PAT-MIND tests a single, full therapeutic dose (either 25 mg or a 5 mg comparator) administered on one single day in a clinical room under direct professional supervision. The goal of PAT is to occasion a temporary, deep altered state of awareness that serves as a therapeutic experience, supported by comprehensive preparation and integration therapy.

What is a Macro-Dose of Psilocybin?

A 'macro-dose' refers to an active dose of psilocybin (such as 25 mg of pharmaceutical PEX010) that produces a full, noticeable altered state of consciousness lasting several hours. At this dose level, individuals typically experience changes in visual perception, deep emotional processing, altered time perception, and shifts in their sense of self. In the PAT-MIND trial, we are testing a 25 mg macro-dose against a 5 mg low-dose comparator to determine how different dose levels interact with mindfulness support to help relieve demoralization in cancer care.

Will I 'Trip,' and What does 'Trip' Mean in a Medical Study?

The word 'trip' is an informal term commonly used to describe the acute 4 to 6-hour period when psilocybin is active in your body. In a medical trial, researchers prefer the term 'altered state of consciousness.' During this time, you may experience vivid mental imagery, intense emotions (such as joy, awe, or grief), changes in how you perceive time and space, and deep reflection on your life and relationships. While the word 'trip' sounds like a recreational journey, in PAT-MIND this experience takes place safely in a quiet room with eyeshades, curated music, and two professional facilitators by your side.

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.

Is Psilocybin or PAT Expected to Cure or Treat my Cancer?

It is vital to understand that psilocybin is NOT a treatment or cure for cancer itself. Psilocybin has no direct anti-tumour or anti-cancer medical effects and will not shrink tumours, slow cancer growth, or replace your oncology treatments. The PAT-MIND trial focuses exclusively on supportive care-specifically helping relieve demoralization, anxiety, loss of meaning, and psychological distress associated with advanced cancer. You will continue all of your necessary standard medical and oncology care while participating in this study.

What is Known and Not Known About the Potential Benefits of PAT?

Published clinical trials from leading universities (such as Johns Hopkins and NYU) show that psilocybin-assisted therapy can produce rapid, substantial, and long-lasting reductions in depression, death anxiety, and demoralization in people with life-threatening cancer. Many participants report enduring improvements in quality of life and spiritual well-being. However, what is not yet fully known is how best to deliver this therapy efficiently in public healthcare systems, whether group-based delivery is as effective as individual care, and how psilocybin interacts with structured mindfulness training. PAT-MIND is designed to answer these exact questions.

SAFETY

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.

What Psychological Risks or Difficult Feelings are Possible During or After Dosing?

During the acute psilocybin session, psychological risks include temporary periods of anxiety, emotional overwhelm, fear of losing control, grief, or confusion. In very rare instances, individuals may experience lingering emotional vulnerability, fatigue, or mood fluctuations in the days following dosing. PAT-MIND is specifically designed to minimize these risks through extensive preparation, continuous facilitator support during dosing, and multi-session integration therapy to help you process difficult emotions safely.

CLINICAL RESEARCH

What is a Clinical Trial?

A clinical trial is a formal medical research study conducted with human volunteers to evaluate new medical treatments, drugs, or psychological therapies. Clinical trials are the gold standard used by health authorities like Health Canada to determine whether an intervention is safe, how well it works, and how it should be delivered in healthcare settings. Every clinical trial follows a strict, ethics-approved plan called a protocol, which outlines exact rules for eligibility, treatment procedures, participant safety monitoring, and privacy protection.

What is a Pilot or a Feasibility Trial?

A pilot or feasibility trial is a preliminary study carried out on a smaller scale (in PAT-MIND, involving approximately 60 participants across two Canadian hospitals) before launching a large national study. The primary goal of a pilot trial is not to definitively prove whether a drug works, but to evaluate operational feasibility: Can we recruit participants smoothly? Is group-based hybrid delivery acceptable to patients? Are safety monitoring protocols working well? The findings from PAT-MIND will directly guide the design of a future Phase III trial across Canada.

What is the PAT-MIND Trial Specifically Trying to Learn?

The PAT-MIND trial is specifically designed to answer three key questions: 1) Feasibility & Safety: Can group-based, hybrid (in-person and virtual) psilocybin-assisted therapy be safely and practically delivered in real-world Canadian cancer centers? 2) Component Optimization: Does adding mindfulness enhance the emotional benefits of psilocybin compared to standard psychological support? 3) Dose Comparison: How does a 25 mg high dose compare to a 5 mg low dose in reducing demoralization? These insights will help us build the most effective, affordable therapy model.

Is this Trial Designed to Prove that PAT Works as a Standard Treatment?

No, this pilot study alone is not designed to provide final proof that PAT works well enough to become a routine, approved medical treatment. Proving definitive clinical effectiveness requires a much larger Phase III trial with hundreds of patients. The job of PAT-MIND is to establish the foundation: testing safety procedures, refining the group therapy curriculum, measuring patient acceptability, and optimizing the dose and therapy combination so that a future nationwide Phase III trial can be conducted with maximum rigor and participant safety.

Who is Conducting, Funding, and Overseeing the PAT-MIND Study?

The PAT-MIND study is led by Principal Investigator Dr. Linda Carlson at the University of Calgary (Arthur Child Comprehensive Cancer Centre) and Sub-site PI Dr. Ron Shore at Queen's University/Providence Care Hospital. The study is funded through competitive national research grants from the Canadian Cancer Society (CCS), Brain Canada, and the Canadian Institutes of Health Research (CIHR). Independent safety oversight is provided by a Data Safety Monitoring Committee (DSMC), Health Canada, and institutional Research Ethics Boards (REBs).

PRACTICAL CONSIDERATIONS

How Many Total Visits are Required and How Long Does the Study Last?

Depending on your assigned therapy arm, PAT-MIND involves either 7 visits (Standard PAT) or 11 visits (Intensive Mindfulness MB-PAT) over an active 6 to 8-week period. This includes 3 to 5 preparation sessions, 1 full dosing day (8 hours), and 3 to 5 integration sessions. Active visits are followed by follow-up check-in questionnaires at Week 1, Week 5-6, and Month 3. The total therapeutic contact time is approximately 12 hours (Standard PAT) or 18 hours (MB-PAT) plus dosing day.

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.

Getting Started

Thinking about taking the next step? This section covers what happens when you express interest in the CAN-PACT pilot study, including eligibility, screening, consent, and what to expect as you get started.

Understanding Demoralization

How is Demoralization Assessed in the PAT-MIND Study?

In the PAT-MIND study, demoralization is assessed using a well-tested, scientific questionnaire called the Demoralization Scale-II (DS-II). This tool consists of 16 brief statements where you rate how strongly you have felt feelings like helplessness or loss of purpose over the past week. It takes about 5 to 10 minutes to complete.

PAT & PSILOCYBIN

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.

CONSENT & PRIVACY

What is Informed Consent in the PAT-MIND Trial?

Informed consent is much more than signing a legal document. In PAT-MIND, informed consent is an ongoing, transparent conversation between you and our research team. It ensures that you receive clear, plain-language explanations of the study purpose, treatment procedures, potential physical and emotional risks, privacy protections, and your absolute rights as a participant. You are given ample time to read the consent form, ask questions, and discuss the decision with loved ones before deciding whether to participate. Consent continues throughout every visit of the trial.

Does Signing the Consent Form Mean I am Locked in and Must Complete the Trial?

No, signing the consent form does NOT lock you in or obligate you to complete the trial. Participation in PAT-MIND is 100% voluntary from start to finish. Signing the form simply confirms that you understand the study details and wish to participate at this time. You retain the absolute right to change your mind, pause participation, decline any specific procedure, or withdraw from the study completely at any point-before, during, or after any visit-without giving a reason and without any impact on your cancer care.

Can I Take the Consent Form Home to Discuss with My Family, Doctors, or Spiritual Advisors?

Yes, absolutely. We strongly encourage you to take the informed consent document home with you before making any decision. You are welcome and invited to discuss participating in PAT-MIND with your family members, caregivers, trusted friends, personal oncologist, family doctor, or spiritual/religious advisers. Taking time to talk through the study details with your support system ensures that you feel completely comfortable, well-supported, and confident in your decision.

Can I Bring a Support Person or Caregiver with Me to Consent and Screening Appointments?

Yes, you are very welcome to bring a spouse, family member, adult child, caregiver, or trusted support person with you to all consent, screening, and orientation appointments. Having a support person present can help you listen to information, ask questions, take notes, and discuss your thoughts afterward. While therapy sessions and dosing days have specific participant-only boundaries to protect group privacy, having your caregiver involved in screening and preparation is warmly welcomed.

Will Session Conversations or Dosing Days be Recorded?

To ensure that our facilitators deliver the therapy consistently and safely according to the study manual, some preparation and integration sessions may be audio or video recorded. These recordings are used exclusively by independent expert raters to evaluate facilitator fidelity and training quality - they DO NOT go beyond the research team or institution. All recordings are encrypted, stored on secure university servers, and destroyed according to research retention rules.

Who Can Access my Medical Records, Study, Data, and Biological Samples?

Your research records, medical data, and biological samples are protected under strict Canadian privacy laws (PIPEDA). All study data is 'de-identified' meaning your name and personal details are replaced with a unique code number. Only authorized study team members at the University of Calgary and Queen's University/Providence Care, Health Canada inspectors, and Research Ethics Boards have access to study records for safety and auditing. Your data will never be sold, shared with insurance companies, or published with identifiable details.

CLINICAL RESEARCH

What is Randomization and Why are Participants Assigned to Groups by Chance?

Randomization is a fundamental clinical trial process where participants are assigned to different treatment groups purely by chance (like flipping a coin, but managed by a secure computer system). Neither you nor your study doctors can choose which group you enter. Randomization is necessary because it ensures that all study groups start out as similar as possible in terms of age, health status, and background. This prevents personal bias from influencing the results and allows scientists to prove whether differences in outcomes are truly caused by the specific therapy or dose tested.

What is the 2x2 Factorial Design, Explained in Plain Language?

The PAT-MIND study uses a '2x2 factorial design' to efficiently test two different treatment factors at the same time: Factor 1 is Psilocybin Dose (High 25 mg vs. Low 5 mg), and Factor 2 is Psychotherapy Intensity (Intensive Mindfulness MB-PAT vs. Standard PAT). Crossing these two factors creates four equal study groups: Group 1 (High Dose + Mindfulness), Group 2 (High Dose + Standard Support), Group 3 (Low Dose + Mindfulness), and Group 4 (Low Dose + Standard Support). Every single participant receives both an active medication capsule and professional therapy, allowing us to learn which combination provides the best emotional relief.

Why Might there be a Waiting Period Before my Therapy Sessions Begin?

After you are accepted into the study, there may be a waiting period of a few weeks before your first prep session begins. This happens because PAT-MIND is a group-based trial. Participants are enrolled in sequential 'recruitment waves' of 3 to 8 people who move through preparation, dosing day, and integration together as a group cohort. Waiting for a wave to form allows everyone in your group to start on the exact same schedule. Our research coordinators will stay in regular contact with you during this waiting window.

What is My Role and Responsibility as a Clinical Trial Participant?

As a clinical trial participant, your primary role is to engage openly and safely with the study process. Responsibilities include: attending scheduled preparation, dosing, and integration visits; completing study questionnaires honestly; wearing your Fitbit device; returning home biological sample kits on time; following post-dosing safety instructions (such as having a responsible adult transport you home); and informing the research team promptly if you experience any unexpected health changes, distress, or medication adjustments.

ELIGIBILITY & SCREENING

Who is Eligible to Participate in the PAT-MIND Study?

Eligibility for PAT-MIND requires meeting several specific criteria: 1) Adults aged 18 years or older of any gender; 2) Diagnosed with Stage III or Stage IV (advanced or metastatic) cancer; 3) Experiencing moderate-to-high demoralization (measured by the DS-II); 4) Medically stable with an estimated life expectancy of at least 6 months; 5) Capable of attending sessions in person and virtually in English; and 6) Having a named responsible adult available to assist with transportation after dosing.

Why are there Multiple Screening Steps and Medical Tests Required?

The PAT-MIND screening process includes three careful steps: Step 1 (Online Pre-Screen), Step 2 (Telephone Conversation & Medical Record Review), and Step 3 (In-Person Medical Exam & Consent). Medical tests-such as checking your blood pressure, reviewing your full medical history, and occasionally an electrocardiogram (ECG) or blood draw if clinically indicated-are required strictly for your safety. Because psilocybin causes temporary increases in blood pressure and heart rate, these checks verify that your cardiovascular and general physical health can safely tolerate the medication.

Why do Certain Medical or Psychiatric Conditions Make Someone Ineligible?

Certain medical and psychiatric conditions make participation unsafe. For example, people with uncontrolled high blood pressure, recent heart attack or stroke, or severe cardiovascular disease cannot participate because psilocybin temporarily elevates heart rate and blood pressure. Similarly, individuals with a personal history of schizophrenia, bipolar disorder, or active psychosis are excluded because psychedelics can potentially trigger or destabilize these conditions. These safety boundaries are required by Health Canada and research ethics boards to protect vulnerable participants from harm.

Why does the Study Team Ask Detailed Questions About my Family Psychiatric History?

During screening, our coordinators ask if any immediate family members (such as parents, siblings, or children) have been diagnosed with schizophrenia, psychotic disorders, or bipolar I disorder. This question is required because scientific evidence shows that classic psychedelics like psilocybin carry a risk of triggering prolonged psychological destabilization or psychosis in people who have a genetic predisposition to these conditions, even if they have never experienced psychosis themselves. Asking about family history is a vital safety measure designed to protect you.

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.

Would I Have to Taper or Stop Taking My Antidepressant to Participate?

In some cases, to experience the full therapeutic benefits of psilocybin, participants taking certain serotonergic antidepressants may be advised to gradually reduce (taper) their medication before dosing day. However, tapering is NEVER mandatory or co-erced. It is an individual medical decision made jointly by you, your prescribing doctor, and our study psychiatrist. If a taper is recommended, a slow, safe step-down plan is created and monitored closely. If tapering is deemed unsafe for your mental health, you will not be forced to taper and can discuss other supportive options.

Who Decides Whether Medication Changes or Tapering are Safe for Me?

Decisions regarding your medications are made through direct collaboration between you, your personal prescribing doctor (such as your family physician, oncologist, or psychiatrist), and the PAT-MIND study doctor. Our study team will never unilaterally change your prescription. We communicate directly with your treating physicians to ensure any recommended adjustments fit safely into your overall cancer care plan. You retain full authority over your care and can decline medication changes at any time.

What Happens if Screening Tests Identify a New or Unexpected Health Concern?

If your screening physical exam, blood tests, or ECG uncover a previously unknown health issue (such as high blood pressure, irregular heart rhythm, or abnormal lab values), our study doctor will discuss the finding with you immediately in plain language. With your permission, we will send the results directly to your family physician or oncologist so you can receive appropriate medical care. If the condition makes psilocybin temporarily unsafe, your participation may be paused until the health issue is treated and stabilized.

What Happens if I am Not Eligible for the Study? Will it Affect My Regular Cancer Care?

If you are found ineligible for PAT-MIND, please know that this is strictly a matter of protocol safety and study rules-it is never a personal rejection. Being ineligible will have absolutely ZERO negative impact on your ongoing cancer treatment, palliative care, or your relationship with your healthcare team. Our research coordinators will explain the exact safety reason for ineligibility and, if you wish, assist in connecting you with other beneficial psychosocial oncology resources, mindfulness programs, or supportive counseling available in your cancer region.

Preparing for Dosing Day

Once you’ve joined the study, preparation helps you get ready for the psilocybin session. This section answers common questions about preparation sessions, what to expect, and how you’ll be supported leading up to dosing day.

CONSENT & PRIVACY

How is My Personal Privacy Protected During Group Therapy Sessions?

Protecting your privacy during group sessions is a top priority. All participants and facilitators sign a binding Group Confidentiality Agreement promising that everything shared within sessions stays strictly within the group. Furthermore, PAT-MIND group facilitation is non-directive-you are never required or pressured to share personal secrets, traumatic memories, or private details. You share only what you feel comfortable disclosing. If you need to discuss something private during dosing day, a separate private room and facilitator are always available.

PARTICIPANT EXPERIENCE

What Happens During Preparation Sessions Before the Dosing Day?

Preparation is the foundation of PAT-MIND, taking place over approximately 2 to 3 weeks before dosing day. Depending on your group assignment, you will attend either 3 prep sessions (Standard PAT) or 5 prep sessions (Intensive Mindfulness MB-PAT). In Visit 1 (individual), you meet your facilitators to discuss your cancer context, goals, and boundaries. In Visits 2 and 3 (group), you meet your cohort peers, establish group safety rules, practice simple breathing and grounding exercises, and discuss your intentions without pressure.

Who are the Therapists/Facilitators and How are they Trained?

PAT-MIND facilitators are regulated, licensed healthcare professionals-such as oncology nurses, clinical social workers, psychologists, spiritual care practitioners, and physicians. All facilitators complete specialized training in the PAT-MIND competency framework, psilocybin pharmacology, group containment, non-directive support, and crisis management. Every group dosing session is staffed by at least two lead facilitators, two trainee facilitators, and an on-site study physician to ensure continuous professional care.

SAMPLES & DATA

Why are Blood Spot and Stool Samples Collected in this Trial?

In addition to evaluating emotional distress, PAT-MIND studies how psilocybin and mindfulness affect physical body systems. Blood spot samples (collected via a simple, small finger-prick device) measure inflammatory markers (like cytokines) and neuroplasticity proteins (BDNF). Stool samples evaluate changes in your gut microbiome. Comparing these biological samples before dosing and after therapy helps scientists discover how mind-body therapies reduce systemic inflammation and support brain healing in cancer care.

How do I Collect Home Blood Spot and Stool Samples and Return Them?

Home sample collection is designed to be simple and painless. At Visit 1, you will receive two home collection kits with step-by-step visual instructions. For the blood sample, you use a tiny, painless finger-prick device (Tasso Tile) that collects a few drops of blood onto a small card. For the stool sample, a hygienic collection tub and scoop are provided. Once collected, you place the samples in pre-labeled packaging, store them in your freezer, and hand them to your coordinator during your next visit.

CLINICAL RESEARCH

Will I Know Which Dose or Therapy Group I will be Assigned to?

In PAT-MIND, you will know which therapy group you are in (Mindfulness MB-PAT or Standard PAT) because the number of prep sessions differs. However, the study is 'double-masked' regarding psilocybin dose: neither you, your facilitators, nor your study doctors will know whether you receive the 25 mg high dose or the 5 mg low dose capsule on dosing day. The capsules look completely identical. Masking the dose is essential to prevent expectations from biasing how you and the facilitators rate your emotional progress. Dose assignments are safely unmasked after the entire study is complete.

Dosing Day

Wondering what happens on dosing day? This section covers what to expect during the psilocybin session, who will be there to support you, safety and monitoring, and what happens before you go home.

PRACTICAL CONSIDERATIONS

Do I Need a Designated Responsible Adult to Pick me Up After the Dosing Day?

Yes, having a named responsible adult available is a mandatory safety requirement for the dosing day. Because psilocybin affects perception and coordination for several hours, you will NOT be allowed to drive a vehicle, take public transit alone, or leave the hospital unassisted after dosing. A designated family member, caregiver, or trusted friend must pick you up directly at the clinic facility at discharge and remain reachable for at least 12 hours after you return home.

PAT & PSILOCYBIN

Will I Lose Control of My Words or Actions During the Session?

It is very natural to worry about losing control when taking a psychoactive medication. In PAT-MIND, you do not become unconscious or lose your moral compass. You remain able to communicate, move, use the restroom, and ask for help. While your emotions and thoughts may feel more intense or fluid, facilitators maintain a quiet, supportive environment that minimizes pressure to speak. You are never forced or coaxed to disclose private personal secrets. Your dignity, personal boundaries, and physical safety are strictly protected by two trained healthcare facilitators at all times.

Can the Psilocybin Experience be Frightening or Overwhelming ('bad trip')?

In psychedelic research, experts prefer to call difficult moments 'challenging experiences' rather than 'bad trips.' Because psilocybin opens up deeper emotional layers, it is possible to encounter feelings of sadness, fear, grief, body tension, or brief panic during the session. These difficult moments are often transient and can lead to meaningful emotional release when properly supported. In PAT-MIND, you are never left alone in distress. Facilitators use a gentle, step-by-step approach-offering calm verbal reassurance, grounding breathwork, or a hand to hold-to help you feel safe and supported as the feeling passes.

Can PAT Change My Personality, Core Values, or Spiritual Beliefs?

PAT-MIND does not change your fundamental personality, core identity, or force new religious or philosophical beliefs upon you. However, many clinical trial participants report that psilocybin helps shift their perspective in positive ways. People living with cancer frequently describe feeling a renewed sense of connection to loved ones, greater appreciation for everyday moments, reduced fear of death, and enhanced self-compassion. The goal of integration therapy is to help you interpret your experience in harmony with your own personal values, personal beliefs, and individual spiritual framework.

PARTICIPANT EXPERIENCE

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 Does the Dosing Room Look and Feel Like?

Although located within a hospital, the PAT-MIND group dosing room is specially designed to feel warm, calm, and non-institutional. It features soft lighting, comfortable recliner chairs or beds, warm blankets, visual artwork, and gentle furnishings. Each participant has their own dedicated recliner space with headphones and eyeshades. While the room feels peaceful and cozy, medical monitoring equipment and emergency medical supplies are discretely accessible in the facility if needed.

What is the Role of Music and Eyeshades During the Dosing Session?

Eyeshades and music are central supportive tools in psychedelic therapy. Wearing light-blocking eyeshades helps you direct your attention inward, reducing external visual distractions and allowing dream-like mental imagery and emotional insights to surface naturally. The curated music playlist acts as an acoustic 'anchor' that supports the natural arc of the psilocybin experience-gentle during onset, deeper during peak intensity, and soothing during descent. You can adjust your headphones or briefly remove eyeshades whenever you need.

How does Group Dosing Work and Will I Have to Interact with Other Participants During Dosing?

In group dosing, 3 to 8 participants lie in comfortable recliners in the same quiet room, each wearing eyeshades and headphones. While you share the safety container of the room and the presence of the facilitator team, your actual psilocybin experience is personal, private, and inward. You are NOT required or expected to talk to, interact with, or process therapy with other participants during the active drug session. Sharing only occurs later during post-dosing group integration sessions if you choose.

What if I Need 1-on-1 Private Support During the Group Dosing Session?

If at any point during the dosing day you feel overwhelmed, need private emotional support, or need a quiet break away from the group, a dedicated private room located directly next door is fully prepared. One of our trained facilitators will accompany you to the private room to provide calm 1-on-1 support for as long as needed. Moving to the private room is completely fine, does not mean anything has gone wrong, and does not affect your participation in the trial.

SAFETY

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.

What Happens if My Blood Pressure or Heart Rate Rises During the Dosing Session?

It is normal for blood pressure and heart rate to increase slightly during a psilocybin session due to emotional intensity and mild stimulant effects. Your vital signs are checked before dosing and monitored throughout the day. If your blood pressure rises above safety thresholds, facilitators first offer calm, relaxing support. If blood pressure remains persistently high, our on-site study doctor can administer standard, fast-acting oral antihypertensive or anti-anxiety medications to safely lower it.

What Happens if I Panic, Feel Confused, or Feel Unsafe During the Session?

If you panic or feel unsafe during dosing, facilitators immediately respond using a gentle, step-by-step approach called the Micro-Intervention Ladder. First, a facilitator sits close by and provides a calm, steadying presence and verbal reassurance ('You are safe, this is temporary'). Next, they may guide you in simple grounding exercises, like feeling your feet or focusing on slow breathing. If you need quiet private space, you can move to the adjacent private room. Medical or anti-anxiety medication is available as a last resort if emotional distress remains unmanageable.

After Dosing Day

What happens after your psilocybin session? This section covers integration, follow-up support, and what to expect in the days and weeks following dosing day.

PARTICIPANT EXPERIENCE

What Happens During Integration Sessions After the Dosing Day?

Integration takes place over the weeks following your dosing day and consists of 3 structured sessions: Visit 5 (individual integration 1-on-1), Visit 6 (group integration with your cohort), and Visit 7 (consolidation and closure). In integration, facilitators help you describe what you experienced-whether visual imagery, deep emotions, memories, or subtle shifts-and reflect on what it means for your life with cancer. Integration is participant-led: you decide what insights feel meaningful and how to apply them to your daily life, relationships, and coping.

What if I do Not Want to Discuss Everything I Experienced During Group Integration?

In group integration, you are in total control of what you choose to share. You are never forced, co-erced, or expected to disclose private thoughts, intense personal memories, or difficult feelings. Many participants find immense value simply in listening quietly to others' experiences and realizing they are not alone. Facilitators strictly enforce group rules preventing advice-giving, judgment, or unwanted probing by others.

What if I Feel Disappointed or do Not Have a Profound, Life-Changing Experience?

Not every psilocybin experience is dramatic, visual, or blissfully transformative-and that is completely normal. Some participants have quiet, subtle, or confusing sessions, or feel disappointed if expectations were high (especially if assigned to the low-dose comparator arm). In PAT-MIND, we emphasize that there is no 'wrong' experience. Subtle shifts in perspective, emotional release, or even realizing what does NOT work for you are valuable. Integration facilitators help you explore whatever occurred safely and constructively, without judgment.

SAFETY

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.

After the Study

What happens when your participation in PAT-MIND comes to an end? This section covers common questions about completing the study, what happens afterward, and what you can expect once your participation is complete.

WITHDRAWAL & POST-STUDY

Will Psilocybin-Assisted Therapy be Available to me After the Study Ends?

No, following the completion of your study visits, additional doses of psilocybin will NOT be provided as a continuation of the PAT-MIND trial. This applies to all participants, including those in the low-dose comparator group. Psilocybin remains a restricted prescription substance outside clinical trials. However, during your final Visit 7 closure session, your study team can provide information on legal access options outside the study-such as Health Canada's Special Access Program (SAP)-and refer you to ongoing community supportive care resources.

How and When will I Receive the Overall Results of the PAT-MIND Study?

We are committed to sharing study findings with the participants who made the research possible. Once all 60 participants have completed the trial and the data has been scientifically analyzed (approximately 18 to 24 months after trial launch), CAN-PACT will publish a plain-language summary of the overall results. This summary will be mailed or emailed to you (or your designated family members). Individual treatment dose unmasking details will also be made available to you at an earlier time directly after you finish your 3 month assessment follow-up.

General Questions About the Study

Some questions aren’t specific to just one stage of PAT-MIND. This section covers general information about participating in the study that may be helpful at any point in your journey.

CONSENT & PRIVACY

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.

PRACTICAL CONSIDERATIONS

What Happens if I am too Fatigued, Unwell, or Hospitalized to Attend a Scheduled Session?

We understand that health fluctuates when living with advanced cancer. If you feel too fatigued, experience acute physical symptoms, or require hospitalization, please notify your research coordinator immediately. Virtual 1-1 therapy sessions can easily be rescheduled or moved to phone calls. If a dosing day needs to be deferred due to temporary illness or high blood pressure, it will be cancelled for you and further participation in the study will be directly discussed with the facilitator and trial team. Your well-being is always prioritized over study timelines.

SAMPLES & DATA

Why are there Repeated Questionnaires Throughout the Study?

You will be asked to complete online questionnaires at Baseline (A1), Dosing Day (A2), Week 1 (A3), Week 5-6 (A4), and Month 3 (A5). Questionnaires measure demoralization (DS-II), anxiety, depression, spiritual well-being, pain, and mindfulness. Repeating these assessments over time allows researchers to map your precise trajectory of emotional recovery, track how long psilocybin benefits last, and evaluate how mindfulness skills consolidate over time. Questionnaires are filled out securely on REDCap (an online data collection platform) and can take anywhere between 15min to 1 hour depending on the number of assessments at that time.

What Happens if my Questionnaire Responses Indicate Suicidal Thoughts or Severe Distress?

Our questionnaires include standard safety questions (Columbia-Suicide Severity Rating Scale) asking about emotional distress and thoughts of death. If your answers indicate active suicidal thoughts or severe psychological distress, the REDCap system automatically flags your survey and alerts our study doctor and research coordinator immediately. A qualified mental health clinician will contact you within 1 hour to check on your safety, offer supportive counseling, and ensure you have immediate help.

SAFETY

What is an Adverse Event and How is Participant Safety Monitored Throughout the Study?

In clinical research, an 'adverse event' (AE) is defined as any untoward or unexpected medical or emotional symptom that occurs while participating in a study, whether or not it is directly caused by the psilocybin. Examples include persistent headache, severe nausea, or prolonged anxiety. All adverse events are logged by research staff and reviewed monthly by Principal Investigators and an independent Data Safety Monitoring Board (DSMB). Serious adverse events are reported to Health Canada within 24 hours to ensure continuous safety oversight.

WITHDRAWAL & POST-STUDY

What if I Decide During the Trial that the Study is No Longer Right for Me?

If you decide at any point that PAT-MIND is no longer right for you, you can stop immediately. Whether you feel too tired, no longer wish to take psilocybin, or simply change your mind, your choice will be fully respected. You will be offered a gentle closing conversation with a facilitator to ensure you feel emotionally supported, but you are not obligated to explain your decision. Your regular oncology and palliative care will continue seamlessly without interruption.

Can I Stop Attending Therapy Sessions but Still Allow the Study Team to Check on My Health?

Yes, absolutely. In clinical trials, you can choose partial withdrawal. For example, if you decide not to take psilocybin or stop attending therapy sessions, you can still choose to let the research team check in with you periodically by phone or complete final follow-up questionnaires. This allows you to step back from active therapy while still contributing valuable safety information to help future cancer patients.

CAN-PACT
Pilot Study Page

GO BACK

PAT-MIND Frequently Asked Questions

How to Use This Page

Learning About the Study

What is Demoralization?

How is Demoralization Different From Depression, Anxiety, Grief, or Normal Cancer Distress?

Why is Demoralization Important to Identify in Cancer Care?

Does Having Demoralization Mean I am Mentally Ill?

Why does PAT-MIND Focus Specifically on Demoralization Rather than General Depression?

Getting Started

How is Demoralization Assessed in the PAT-MIND Study?

Preparing for Dosing Day

How is My Personal Privacy Protected During Group Therapy Sessions?

Dosing Day

Do I Need a Designated Responsible Adult to Pick me Up After the Dosing Day?

After Dosing Day

What Happens During Integration Sessions After the Dosing Day?

What if I do Not Want to Discuss Everything I Experienced During Group Integration?

What if I Feel Disappointed or do Not Have a Profound, Life-Changing Experience?

After the Study

Will Psilocybin-Assisted Therapy be Available to me After the Study Ends?

How and When will I Receive the Overall Results of the PAT-MIND Study?

General Questions About the Study

Can I Withdraw from the Study at Any Time Without Giving a Reason?

CAN-PACT Pilot Study Page

PAT-MIND
Frequently Asked Questions

CAN-PACT
Pilot Study Page