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MB-PAT for Demoralization in Advanced Cancer ('PAT-MIND') Trial

ConditionsAdvanced CancerDemoralizationExistential DistressPsychological Distress
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary

About this trial

This pilot clinical trial will study psilocybin-assisted therapy for adults with advanced cancer who are experiencing demoralization, existential distress, or related psychological concerns. Demoralization can include feelings of hopelessness, helplessness, loss of meaning, and distress related to illness or end of life.

The purpose of this study is to assess whether a hybrid group-based psilocybin-assisted therapy program is feasible, acceptable, and safe in adults with advanced cancer. The study will also explore which combination of psilocybin dose and psychotherapy approach may be most promising for a future larger trial.

Participants will be randomly assigned by wave to one of four intervention combinations: 25 mg psilocybin with mindfulness-based psilocybin-assisted therapy, 25 mg psilocybin with standard psilocybin-assisted therapy, 5 mg psilocybin with mindfulness-based psilocybin-assisted therapy, or 5 mg psilocybin with standard psilocybin-assisted therapy. The psilocybin dose will be blinded, meaning participants and some members of the study team will not know which dose was assigned. Psychotherapy approach will not be blinded. The study will enroll at least 60 participants across Calgary and Kingston.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent provided before any study-specific procedures.

Age 18 years or older.

Diagnosis of advanced cancer: Stage III-IV or metastatic solid tumor. Stage II cancer may be eligible if the treating oncologist confirms advanced/refractory disease with clinically significant existential burden, defined as a Demoralization Scale-II (DS-II) score ≥11.

Clinical life expectancy of at least 6 months. Borderline cases of approximately 5-6 months may be considered based on Principal Investigator judgment and documentation.

Disqualifiers

Active or high-risk suicidality, defined as Columbia-Suicide Severity Rating Scale (C-SSRS) item 4 or 5 within the past 4 weeks, or a suicide attempt within the past 12 months. Passive death wishes and suicidal ideation without intent are not exclusionary.

Current psychotic disorder or active psychotic symptoms, including schizophrenia, schizoaffective disorder, hallucinations, delusions, or thought disorganization. Historical psychosis in sustained remission may be considered on a case-by-case basis by the Principal Investigator.

Current manic or mixed-state episode. Stable, euthymic bipolar disorder on maintenance pharmacotherapy may be permitted with Principal Investigator judgment and documentation.

Moderate-to-severe active alcohol, stimulant, or opioid use disorder within the past 12 months. Severe uncontrolled cannabis use disorder is exclusionary; stable prescribed cannabis use is permitted.

Trial design

Design model

Factorial

Treatments tested in this trial

  • PEX010 25 mg psilocybin

    Drug

    Participants randomized to this dose condition will receive a single 25 mg oral dose of PEX010 (psilocybin) during a monitored in-person group dosing session, together with protocol-defined psychotherapeutic support

  • PEX010 5 mg psilocybin

    Drug

    Participants randomized to this dose condition will receive a single 5 mg oral dose of PEX010 (psilocybin) during a monitored in-person group dosing session, together with protocol-defined psychotherapeutic support. This is a blinded low-dose active comparator condition.

  • Standard Psilocybin-Assisted Therapy

    Behavioral

    Participants randomized to this psychotherapy condition will receive standard psilocybin-assisted therapy, including protocol-defined preparation, dosing-day support, and integration sessions. The intervention is delivered in a hybrid format, with some sessions conducted in person and some virtually, depending on session type and site logistics.

  • Mindfulness-Based Psilocybin-Assisted Therapy

    Behavioral

    Participants randomized to this psychotherapy condition will receive mindfulness-based psilocybin-assisted therapy, including protocol-defined preparation, dosing-day support, and integration sessions. The intervention includes mindfulness-based therapeutic elements and is delivered in a hybrid format, with some sessions conducted in person and some virtually, depending on session type and site logistics.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: 25 mg Psilocybin + Standard PATExperimental treatment 2 interventions
Group B: 25 mg Psilocybin + Mindfulness-Based PATExperimental treatment 2 interventions
Group C: 5 mg Psilocybin + Standard PATExperimental treatment 2 interventions
Group D: 5 mg Psilocybin + Mindfulness-Based PATExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Trial Feasibility Based on Prespecified RED/YELLOW/GREEN Progression Criteria

Overall trial feasibility will be assessed using prespecified progression criteria covering recruitment, intervention delivery, and retention. Component metrics include screening completion among referred individuals, eligibility among screened individuals, enrollment among eligible individuals, preparation-session attendance, integration-session attendance, completion of the 1-week post-dose assessment (A3), and completion of the 3-month follow-up (A5). Each component will be expressed as a proportion and classified according to prespecified RED (review), YELLOW (amend), or GREEN (go) thresholds. The overall feasibility classification will be determined by the worst-performing component, resulting in a single overall RED/YELLOW/GREEN progression classification. Feasibility will be assessed pooled across all four intervention arms.

Time frame
From initial referral/screening through the 3-month follow-up (A5), up to approximately 4 months
2

Incidence of Adverse Events (AEs)

Safety will be assessed in all participants who receive psilocybin. Adverse events will be collected from informed consent through the 3-month follow-up (A5) and summarized as the number and proportion of participants experiencing one or more adverse events. Events will be characterized by severity, relationship to psilocybin, dose group, and timing. Serious adverse events (SAEs) and protocol-defined adverse events of special interest (AESIs) will be identified and summarized as prespecified safety categories.

Time frame
From informed consent through the 3-month follow-up (A5), approximately up to 4 months

Secondary outcomes

1

Change in Demoralization Scale-II (DS-II) Total Score

Demoralization will be assessed using the Demoralization Scale-II (DS-II), a 16-item self-report measure. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 32. Higher scores indicate greater demoralization (a worse outcome). The outcome is the change in DS-II total score from baseline (A1) to 1 week post-dosing (A3).

Time frame
Baseline to 1 week post-dose
2

Change in anxiety symptoms assessed by PROMIS Anxiety Short Form 8a

Anxiety symptoms will be assessed using the 8-item PROMIS Anxiety Short Form 8a. Change in anxiety will be evaluated from baseline across post-dose follow-up assessments.

Time frame
Baseline through 3 months post-dose
3

Change in depressive symptoms assessed by PROMIS Depression Short Form 8a

Depressive symptoms will be assessed using the 8-item PROMIS Depression Short Form 8a. Change in depressive symptoms will be evaluated from baseline across post-dose follow-up assessments.

Time frame
Baseline through 3 months post-dose
4

Change in Death and Dying Distress Scale (DADDS) Total Score

Death and dying distress will be assessed using the 15-item Death and Dying Distress Scale (DADDS). Each item is scored from 0 to 5, yielding a total score ranging from 0 to 75. Higher scores indicate greater death and dying distress and therefore a worse outcome. Change in DADDS total score will be evaluated from baseline across post-dose follow-up assessments.

Time frame
Baseline through 3 months post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Providence Care, Kingston, ON, Canada

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: