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| Name | Class |
|---|---|
| Oppenheimer Family Psychosocial Oncology and Palliative Care Research Grants | UNKNOWN |
| Usona Institute | OTHER |
| Carey and Claudia Turnbull Family Foundation | UNKNOWN |
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The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care.
-The name of the study drug involved in this study is Psilocybin
The purpose of this research is to understand how psilocybin-assisted therapy may be adapted in the context of hospice care, in order to test its safety in people with terminal illness who experience demoralization, and to study how well it works to lessen symptoms of psychological and existential distress.
This research study involves a combined drug and psychotherapeutic (talk therapy) intervention. The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits.
Participants will be followed for up to 24 weeks (approximately 6 months) after the study treatment. It is expected that about 15 people will take part in this research study.
This research study is a Feasibility Study, which mean it is the first time investigators are examining psilocybin-assisted therapy in the context of hospice care. Psilocybin is an "Investigational" drug, meaning that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. However, the FDA has granted psilocybin the status of "breakthrough therapy" in the treatment of depression and the investigators have permission from the FDA to use this drug in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PATH | Experimental | The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. -The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Oral, single administration, dosage 25 mg orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Screened Per Study Period | This measurement will assess enrollment feasibility based on the screening log. | Through study completion, through 22 months |
| Eligible Population | Number of screened hospice patients who met pre-eligibility criteria and were approached for consent | Through study completion, over 22 months |
| Number of Participants Enrolled Over Study Period | This measurement will assess enrollment feasibility based on the screening log. | Through study completion, over 22 months |
| Average Time From Screening to Enrollment | This measurement will assess enrollment feasibility based on the screening log. | From date of screening until the date of enrollment, assessed up to 12 months |
| Number of Therapy Sessions Completed by Enrolled Participants | Therapy sessions included 5 sessions: 2 preparation visits (V1 and V2), dosing (V3) and 2 integration visits (V4 and V5) | Through study completion, a period of 22 months |
| Mean Score of Acceptability Ratings on Reactions to Research Participation Questionnaire Revised (RRPQR) | The RRPQ-R is a validated 23-item instrument designed to assess participants' experiences and perceptions of research participation. It comprises five subscales: participation (7 items, range 7-35), personal benefit (5 items, range 5-25), emotional reactions (6 items, range 6-30), perceived drawbacks (3 items, range 3-15), and global evaluation (2 items, range 2-10). Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores on participation, personal benefit, and global evaluation indicate more positive perceptions, while higher scores on emotional reactions and perceived drawbacks reflect greater negative emotional or practical impact. A total score can be calculated by summing across all items (range 23-115), with higher scores reflecting more favorable overall experiences of research participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) | The FACIT-Pal-14 is a validated 14-item measure of quality of life in palliative care populations. Items assess physical, emotional, social, and functional well-being over the past 7 days using a 5-point Likert scale (0 = not at all to 4 = very much). Scores are summed to produce a total score ranging from 0 to 56, with higher scores reflecting better quality of life. Subscale scores are not typically reported separately, but can be derived if needed by summing relevant items. The measure is widely used in palliative and supportive care research to evaluate patient-centered outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
Current General Inpatient (GIP) hospice status
Patients currently receiving chemotherapy
Condition impairing oral intake or digestive absorption
Presence of a delirium diagnosed by the CAM
Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on item 5 on the C-SSRS within the past month or at V0
Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history
Patients with first-degree relatives with schizophrenia or bipolar disorder
History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin
Other personal circumstances and behavior that would limit compliance with study requirements, or judged by the study psychiatrist and/or principal investigator to be incompatible with establishment of rapport or safe exposure to psilocybin
Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:
Any psychiatric medication will be tapered if possible in an appropriate fashion to avoid withdrawal effects. They will be discontinued long enough before the psilocybin Session to avoid the possibility of any drug-drug interaction (the interval will be at least five times the particular drug and active metabolites' half-life).
End stage liver disease or cirrhosis as primary hospice diagnosis
Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork and patients with symptoms suggestive of liver failure including confusion, asterixis or jaundice.
Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study. This may include but is not limited to clinical symptoms or recent history of significant tachyarrhythmias; severe angina or myocardial ischemia; poorly controlled congestive heart failure; poorly controlled hypertension; poorly controlled hypo- or hyperthyroidism; uncontrolled diabetes; severe renal or liver disfunction; acute respiratory failure; sepsis; history of cerebral aneurysms; glaucoma; increased intracranial pressure and any intracranial mass.
Women who are pregnant, nursing, or planning a pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Yvan Beaussant, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Dimensions | Danvers | Massachusetts | 01923 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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If the participant is being treated with psychiatric drugs at the time they are recruited, they will discuss medication tapering with the study psychiatrist and the hospice physician. If needed, the drugs will then be tapered in an appropriate fashion to avoid withdrawal effects. They will be discontinued long enough before the first Experimental Session to avoid the possibility of any drug-drug interaction (the interval will be >/= 5x the particular drug and active metabolites' half-life).
The study population will include 15 adult patients, 21 years or older, who receive hospice care at home from Care Dimensions hospice in Massachusetts. The study team will screen potential participants by reviewing new admissions and reviewing the current census on a reoccurring basis. For potentially eligible patients, the study team will contact a referent hospice clinician (nurse case manager or physician) to discuss the patient case and confirm the possibility to further the consent process.
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| ID | Title | Description |
|---|---|---|
| FG000 | PATH | The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. -The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions Psilocybin: Oral, single administration, dosage 25 mg orally Psychotherapy: The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2023 |
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| Heffter Research Institute |
| OTHER |
| George Sarlo Foundation | UNKNOWN |
| RiverStyx Foundation | OTHER |
| Council on Spiritual Practices Fund at the San Francisco Foundation | UNKNOWN |
| Nikean Foundation | UNKNOWN |
| Jack Smith | UNKNOWN |
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| Psychotherapy |
| Behavioral |
The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions |
|
| At Week 1 post dosing session |
| At Baseline, and weeks 1, 3, and 7 |
| Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS) | The PROMIS Pain Interference Scale (8a) is a validated 8-item instrument assessing the extent to which pain hinders engagement in social, emotional, cognitive, and physical activities. Items are rated over the past 7 days on a 5-point Likert scale (1 = not at all to 5 = very much). Raw scores range from 8 to 40 and are converted to standardized T-scores (mean = 50, SD = 10) using PROMIS scoring manuals. Higher scores indicate greater interference of pain with daily functioning. The measure is administered only if pain is reported and allows both raw and T-score interpretations to facilitate comparison across studies. | At Baseline, and weeks 1, 3, and 7 |
| Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | It is a self-report questionnaire consisting of 14 items, and subjects rate how they felt during the previous week on a 4-point Likert scale. The HADS consists of an anxiety and depression subscale (0-21 points each), and total scores can range from 0 to 42. Higher scores indicate more severe depression and anxiety. | At Baseline, and weeks 1, 3, and 7 |
| Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) Score | The LAP-R Death Acceptance subscale is a validated 8-item measure assessing acceptance of and anxiety about death. Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Subscale scores are calculated by summing item responses, yielding a total range of 9 to 56, with higher scores reflecting greater acceptance of death and lower death-related anxiety. The measure is commonly used in palliative care and existential research to evaluate psycho-existential adjustment in serious illness. | At Baseline, and weeks 1, 3, and 7 |
| Challenging Experience Questionnaire (CEQ) Score | The CEQ is a validated 26-item instrument assessing psychologically and somatically difficult aspects of psilocybin experiences. It consists of seven subscales: grief (3 items, range 3-15), fear (6 items, range 6-30), death (3 items, range 3-15), insanity (3 items, range 3-15), isolation (3 items, range 3-15), physical distress (3 items, range 3-15), and paranoia (5 items, range 5-25). Items are rated on a 5-point Likert scale (1 = not at all to 5 = extremely). Subscale scores are computed by summing responses within each domain, with higher scores indicating more challenging experiences. A total score (range 26-130) may also be calculated by summing across all items, providing a global index of psychological challenge. | Immediately after the intervention, at the end of the dosing day |
| Change in Social Isolation Scale (SIS) Score | The PROMIS Social Isolation Scale-6a is a validated 6-item short form that measures perceived social disconnection, including feelings of exclusion, detachment, and lack of belonging. Items are rated on a 5-point Likert scale (1 = never to 5 = always). Raw scores range from 6 to 30 and are converted to standardized T-scores (mean = 50, SD = 10) based on PROMIS scoring guidelines. Higher scores represent greater perceived social isolation. The measure is widely used in psychosocial and palliative care research to assess the impact of illness on social well-being. | At Baseline, and weeks 1, 3, and 7 |
| Change in Spiritual Domain Score as Assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) | The FACIT-Sp-12 is a validated 12-item measure widely used in cancer and palliative care to assess spiritual well-being. It includes three subscales: meaning (4 items, range 0-16), peace (4 items, range 0-16), and faith (4 items, range 0-16). Items are rated on a 5-point Likert scale (0 = not at all to 4 = very much). Subscale scores are summed, and a total score (range 0-48) is obtained by summing across all items. Higher scores indicate greater spiritual well-being. The FACIT-Sp-12 is one of the most commonly used measures of spirituality in serious illness research and has strong psychometric validity. | At Baseline, and weeks 1, 3, and 7 |
| Change in Demoralization Scale (DS-II) | The DS-II is a validated 16-item self-report measure of demoralization, capturing experiences of disheartenment, helplessness, and loss of meaning. It comprises two subscales: meaning and purpose (8 items, range 0-16) and distress and coping ability (8 items, range 0-16). Items are rated on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Subscale scores are summed, and a total score (range 0-32) is calculated by adding across all items, with higher scores indicating greater demoralization. For Version 5 (V5), items are anchored to the past week rather than the past two weeks in the original version, improving temporal sensitivity in clinical research. | At Baseline, and weeks 1, 3, and 7 |
| Mystical Experience Questionnaire (MEQ-30) | The MEQ-30 is a validated 30-item self-report instrument assessing the phenomenological features of mystical-type experiences induced by psychedelics. It yields four subscales: mystical (15 items, range 0-75), positive mood (6 items, range 0-30), transcendence of time and space (6 items, range 0-30), and ineffability (3 items, range 0-15). Items are rated on a 6-point Likert scale (0 = none to 5 = extreme). Subscale scores are summed, and a total score (range 0-150) is calculated by summing across all items. Higher scores indicate stronger mystical-type experiences, with ≥60% of the maximum possible score on each subscale often used as a criterion for a "complete" mystical experience. | Immediately after the intervention, at the end of the dosing day |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PATH | The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. -The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions Psilocybin: Oral, single administration, dosage 25 mg orally Psychotherapy: The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Relationship Status | Count of Participants | Participants |
| ||||||||||||||||||||
| Education | Count of Participants | Participants |
| ||||||||||||||||||||
| Diagnosis | Count of Participants | Participants |
| ||||||||||||||||||||
| Baseline Palliative Performance Scale | The Palliative Performance Scale (PPS) is a clinician-rated tool measuring functional status in palliative care. Scores range from 0% (death) to 100% (full function), in 10% increments. It assesses ambulation, activity, self-care, intake, and consciousness. Higher scores indicate better function; lower scores reflect decline. The PPS yields a single score (no subscales), based on clinical judgment. Unit of measure: scores on a scale. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Screened Per Study Period | This measurement will assess enrollment feasibility based on the screening log. | Home hospice population | Posted | Number | participants | Through study completion, through 22 months |
|
|
| ||||||||||||||||||||||||||
| Primary | Eligible Population | Number of screened hospice patients who met pre-eligibility criteria and were approached for consent | Posted | Count of Participants | Participants | Through study completion, over 22 months |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants Enrolled Over Study Period | This measurement will assess enrollment feasibility based on the screening log. | Posted | Number | participants | Through study completion, over 22 months |
|
| ||||||||||||||||||||||||||||
| Primary | Average Time From Screening to Enrollment | This measurement will assess enrollment feasibility based on the screening log. | Participants who were enrolled in the study. | Posted | Mean | Full Range | days | From date of screening until the date of enrollment, assessed up to 12 months |
|
| ||||||||||||||||||||||||||
| Primary | Number of Therapy Sessions Completed by Enrolled Participants | Therapy sessions included 5 sessions: 2 preparation visits (V1 and V2), dosing (V3) and 2 integration visits (V4 and V5) | Posted | Count of Participants | Participants | Through study completion, a period of 22 months |
|
| ||||||||||||||||||||||||||||
| Primary | Mean Score of Acceptability Ratings on Reactions to Research Participation Questionnaire Revised (RRPQR) | The RRPQ-R is a validated 23-item instrument designed to assess participants' experiences and perceptions of research participation. It comprises five subscales: participation (7 items, range 7-35), personal benefit (5 items, range 5-25), emotional reactions (6 items, range 6-30), perceived drawbacks (3 items, range 3-15), and global evaluation (2 items, range 2-10). Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores on participation, personal benefit, and global evaluation indicate more positive perceptions, while higher scores on emotional reactions and perceived drawbacks reflect greater negative emotional or practical impact. A total score can be calculated by summing across all items (range 23-115), with higher scores reflecting more favorable overall experiences of research participation. | Posted | Mean | Standard Deviation | score on a scale | At Week 1 post dosing session |
| ||||||||||||||||||||||||||||
| Secondary | Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) | The FACIT-Pal-14 is a validated 14-item measure of quality of life in palliative care populations. Items assess physical, emotional, social, and functional well-being over the past 7 days using a 5-point Likert scale (0 = not at all to 4 = very much). Scores are summed to produce a total score ranging from 0 to 56, with higher scores reflecting better quality of life. Subscale scores are not typically reported separately, but can be derived if needed by summing relevant items. The measure is widely used in palliative and supportive care research to evaluate patient-centered outcomes. | Treated participants | Posted | Mean | 95% Confidence Interval | score on a scale | At Baseline, and weeks 1, 3, and 7 |
| |||||||||||||||||||||||||||
| Secondary | Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS) | The PROMIS Pain Interference Scale (8a) is a validated 8-item instrument assessing the extent to which pain hinders engagement in social, emotional, cognitive, and physical activities. Items are rated over the past 7 days on a 5-point Likert scale (1 = not at all to 5 = very much). Raw scores range from 8 to 40 and are converted to standardized T-scores (mean = 50, SD = 10) using PROMIS scoring manuals. Higher scores indicate greater interference of pain with daily functioning. The measure is administered only if pain is reported and allows both raw and T-score interpretations to facilitate comparison across studies. | Treated participants who completed the questionnaire. | Posted | Mean | 95% Confidence Interval | score on a scale | At Baseline, and weeks 1, 3, and 7 |
| |||||||||||||||||||||||||||
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | It is a self-report questionnaire consisting of 14 items, and subjects rate how they felt during the previous week on a 4-point Likert scale. The HADS consists of an anxiety and depression subscale (0-21 points each), and total scores can range from 0 to 42. Higher scores indicate more severe depression and anxiety. | Treated participants who completed the questionnaire. | Posted | Mean | 95% Confidence Interval | score on a scale | At Baseline, and weeks 1, 3, and 7 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) Score | The LAP-R Death Acceptance subscale is a validated 8-item measure assessing acceptance of and anxiety about death. Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Subscale scores are calculated by summing item responses, yielding a total range of 9 to 56, with higher scores reflecting greater acceptance of death and lower death-related anxiety. The measure is commonly used in palliative care and existential research to evaluate psycho-existential adjustment in serious illness. | Treated participants who completed the questionnaire. | Posted | Mean | 95% Confidence Interval | score on a scale | At Baseline, and weeks 1, 3, and 7 |
|
| ||||||||||||||||||||||||||
| Secondary | Challenging Experience Questionnaire (CEQ) Score | The CEQ is a validated 26-item instrument assessing psychologically and somatically difficult aspects of psilocybin experiences. It consists of seven subscales: grief (3 items, range 3-15), fear (6 items, range 6-30), death (3 items, range 3-15), insanity (3 items, range 3-15), isolation (3 items, range 3-15), physical distress (3 items, range 3-15), and paranoia (5 items, range 5-25). Items are rated on a 5-point Likert scale (1 = not at all to 5 = extremely). Subscale scores are computed by summing responses within each domain, with higher scores indicating more challenging experiences. A total score (range 26-130) may also be calculated by summing across all items, providing a global index of psychological challenge. | Treated participants who completed the questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Immediately after the intervention, at the end of the dosing day |
| |||||||||||||||||||||||||||
| Secondary | Change in Social Isolation Scale (SIS) Score | The PROMIS Social Isolation Scale-6a is a validated 6-item short form that measures perceived social disconnection, including feelings of exclusion, detachment, and lack of belonging. Items are rated on a 5-point Likert scale (1 = never to 5 = always). Raw scores range from 6 to 30 and are converted to standardized T-scores (mean = 50, SD = 10) based on PROMIS scoring guidelines. Higher scores represent greater perceived social isolation. The measure is widely used in psychosocial and palliative care research to assess the impact of illness on social well-being. | Treated participants who completed the questionnaire. | Posted | Mean | 95% Confidence Interval | score on a scale | At Baseline, and weeks 1, 3, and 7 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Spiritual Domain Score as Assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) | The FACIT-Sp-12 is a validated 12-item measure widely used in cancer and palliative care to assess spiritual well-being. It includes three subscales: meaning (4 items, range 0-16), peace (4 items, range 0-16), and faith (4 items, range 0-16). Items are rated on a 5-point Likert scale (0 = not at all to 4 = very much). Subscale scores are summed, and a total score (range 0-48) is obtained by summing across all items. Higher scores indicate greater spiritual well-being. The FACIT-Sp-12 is one of the most commonly used measures of spirituality in serious illness research and has strong psychometric validity. | Treated participants who completed the questionnaire. | Posted | Mean | 95% Confidence Interval | score on a scale | At Baseline, and weeks 1, 3, and 7 |
| |||||||||||||||||||||||||||
| Secondary | Change in Demoralization Scale (DS-II) | The DS-II is a validated 16-item self-report measure of demoralization, capturing experiences of disheartenment, helplessness, and loss of meaning. It comprises two subscales: meaning and purpose (8 items, range 0-16) and distress and coping ability (8 items, range 0-16). Items are rated on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Subscale scores are summed, and a total score (range 0-32) is calculated by adding across all items, with higher scores indicating greater demoralization. For Version 5 (V5), items are anchored to the past week rather than the past two weeks in the original version, improving temporal sensitivity in clinical research. | Treated participants who completed the questionnaire. | Posted | Mean | 95% Confidence Interval | score on a scale | At Baseline, and weeks 1, 3, and 7 |
| |||||||||||||||||||||||||||
| Secondary | Mystical Experience Questionnaire (MEQ-30) | The MEQ-30 is a validated 30-item self-report instrument assessing the phenomenological features of mystical-type experiences induced by psychedelics. It yields four subscales: mystical (15 items, range 0-75), positive mood (6 items, range 0-30), transcendence of time and space (6 items, range 0-30), and ineffability (3 items, range 0-15). Items are rated on a 6-point Likert scale (0 = none to 5 = extreme). Subscale scores are summed, and a total score (range 0-150) is calculated by summing across all items. Higher scores indicate stronger mystical-type experiences, with ≥60% of the maximum possible score on each subscale often used as a criterion for a "complete" mystical experience. | Treated participants who completed the questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Immediately after the intervention, at the end of the dosing day |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psilocybin- Single Arm | The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. -The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions Psilocybin: Oral, single administration, dosage 25 mg orally Psychotherapy: The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions | 9 | 15 | 10 | 15 | 13 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | CTCAE v5 | Systematic Assessment | First episode of symptomatic ascites (pain, nausea, vomiting and shortness of breath) leading to admission at hospice facility as GIP during one week. Related to terminal illness (bile duct cancer). |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE v5 | Systematic Assessment | Increased Abdominal Pain related to terminal illness progression (colon cancer with mets to liver and lung) - Admitted GIP at the Hospice House for complex pain management. Patient was Off Treatment at that time. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v5 | Systematic Assessment | Sudden episode of dyspnea around 5pm, resulting in death shortly after. |
|
| Hip fracture | Musculoskeletal and connective tissue disorders | CTCAE v5 | Systematic Assessment | Participant fell at his home and fractured his right femoral neck. Hospitalization required. |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE v5 | Systematic Assessment | Progressive decline due to underlying disease (lung fibrosis). Patient found to be deceased by son on morning of 1/8/23. At this time, patient was Off Treatment after completing the therapeutic intervention per protocol. |
|
| Cardiac arrest | Cardiac disorders | CTCAE v5 | Systematic Assessment | Death occured due to terminal illness progression. |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE v5 | Systematic Assessment | Increased dyspnea, somnolence and confusion at home despite O2 5L. GIP admission for end of life symptom management. Participant passed away due to terminal illness progression (interstitial lung disease). |
|
| Depressed level of consciousness | Nervous system disorders | CTCAE v5 | Systematic Assessment | Patients found unconscious on the floor. |
|
| Pain | General disorders | CTCAE v5 | Systematic Assessment | Significant increase of pain necessiting GIP admission. |
|
| Nausea | Gastrointestinal disorders | CTCAE v5 | Systematic Assessment | Nausea. At this time, patient was Off Treatment after completing the therapeutic intervention per protocol. |
|
| Fatigue | General disorders | CTCAE v5 | Systematic Assessment | Noted weakness in patient chart. At this time, patient was Off Treatment after completing the therapeutic intervention per protocol. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE v5 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v5 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v5 | Systematic Assessment |
| |
| Hypoglycemia | Endocrine disorders | CTCAE v5 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v5 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | CTCAE v5 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE v5 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v5 | Systematic Assessment |
| |
| Anger | Psychiatric disorders | CTCAE v5 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE v5 | Systematic Assessment |
| |
| Crying | Psychiatric disorders | CTCAE v5 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE v5 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v5 | Systematic Assessment |
|
This pilot study is limited by its small sample size, lack of control group, and homogeneous participant demographics. Its single-site design further limits generalizability. Additionally, due to the rapidly evolving clinical condition of participants, missing data at later time points limited our ability to assess medium to long-term outcomes.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yvan Beaussant | Dana-Farber Cancer Institute | 617-582-9318 | patresearch@dfci.harvard.edu |
| Jul 9, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D004191 | Behavioral Disciplines and Activities |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Single, never married |
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| Widowed/Loss of long-term partner |
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| 2 years of college /technical school |
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| College graduate (BS or BA) |
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| Master's degree |
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| Doctorate/Medical degree/Law degree |
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| GYN cancers |
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| Light chain amyloidosis |
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| Pulmonary fibrosis |
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| Chronic lung allograft rejection |
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