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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-13913 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00001905 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| EU5206-20 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain. Cancer patients often experience demoralization, which is characterized by feelings of hopelessness, loss of meaning, and existential distress. Psilocybin psychotherapy, together with multidisciplinary palliative and supportive care, may help treat the anxiety, depression, and chronic pain felt by cancer survivors - defined here as cancer patients from time of diagnosis through the end-of-life.
PRIMARY OBJECTIVE:
I. To determine the safety, feasibility, and acceptability of a single administration of 25 mg psilocybin (psilocybin) provided under supportive conditions with multidisciplinary palliative care support (P-PC) in adult cancer survivors living with concurrent demoralization and chronic pain.
EXPLORATORY OBJECTIVE:
I. To evaluate for changes in demoralization, anxiety, depression, quality of life, pain, other symptoms, mysticism, awe, post-traumatic growth, social isolation, and psychosocial functioning from baseline to end-of-treatment to 3.5-month follow up.
OUTLINE:
Patients receive psilocybin orally (PO) and undergo observation for up to 8 hours on day 14.
After completion of study intervention, patients are followed up on days 15, 21, 42, 56, and 98.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (psilocybin, observation) | Experimental | Patients receive psilocybin PO and undergo observation for up to 24 hours on day 14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher | Adverse events are graded according to Common Terminology Criteria for Adverse Events. Descriptive statistics will summarize the incidence and duration of adverse events, with the primary outcome of interest being the incidence of medical Grade 3 or higher or psychiatric Grade 4 or higher Common Terminology Criteria for Adverse Events considered by the PI to be treatment-related occurring by day 42. These events will be evaluated by adverse events, vital signs, ECG, and laboratory findings. A successful outcome is no medical or psychiatric Grade 4 adverse events or higher. | Up to 42 days |
| Evaluation of Feasibility Outcome To Assess Patient Retention in The Study | Feasibility will be assessed by patient retention in the study, number of missed events, a survey assessing acceptability of the protocol at study endpoint, and fidelity to the intervention elements. A successful outcome is retention of 80% of subjects enrolled in the study, 80% of events attended by subjects, and 60% of subjects find intervention satisfactory. | Up to 42 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate for Changes in Demoralization at Forty-Two Days | Evaluate demoralization using the Demoralization Scale from baseline to end-of-treatment to 3.5-month follow up. Moderate-to-severe demoralization (score of ≥ 10 on the Demoralization Scale-II). | At 42 days |
| Evaluate for Changes in Demoralization at Ninety-Eight Days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali J. Zarrabi, MD | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States | ||
| Brain Health Center at Executive Park |
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| Psychotherapy | Behavioral | supportive care |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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Evaluate demoralization using the Demoralization Scale from baseline to end-of-treatment to 3.5-month follow up. Moderate-to-severe demoralization (score of ≥ 10 on the Demoralization Scale-II). |
| At 98 days |
| Impact of Pain Intensity and Interference with Daily Functioning at Forty-Two Days | The impact of pain intensity and interference with daily functioning will be assessed using Brief Pain Inventory. Chronic pain (pain lasting > 3 months per patient report) and score of ≥ 5 for average pain level on Brief Pain Inventor. | At 42 days |
| Impact of Pain Intensity and Interference with Daily Functioning at Ninety-Eight Days | The impact of pain intensity and interference with daily functioning will be assessed using Brief Pain Inventory. Chronic pain (pain lasting > 3 months per patient report) and score of ≥ 5 for average pain level on Brief Pain Inventor. | At 98 days |
| Global Symptom Burden at Forty-Two Days | Global symptom burden will be evaluated using the Edmonton Symptom Assessment Scale.The scale ranges from 0 representing no symptom to 10 representing maximum symptom. | At 42 days |
| Global Symptom Burden at Ninety-Eight Days | Global symptom burden will be evaluated using the Edmonton Symptom Assessment Scale.The scale ranges from 0 representing no symptom to 10 representing maximum symptom. | At 98 days |
| Anxiety and Depression at Forty-Two Days | Anxiety and Depression is evaluated using the Hospital Anxiety and Depression Scale. The Hospital Anxiety and Depression Scale is a 14-item self-report scale and reliable instrument for detecting states of depression and anxiety in outpatient settings, where 0-7 = Normal, 8-10 = Borderline abnormal (borderline case) and 11-21 = Abnormal (case). | At 42 days |
| Anxiety and Depression at Ninety-Eight Days | Anxiety and Depression is evaluated using the Hospital Anxiety and Depression Scale. The Hospital Anxiety and Depression Scale is a 14-item self-report scale and reliable instrument for detecting states of depression and anxiety in outpatient settings, where 0-7 = Normal, 8-10 = Borderline abnormal (borderline case) and 11-21 = Abnormal (case). | At 98 days |
| Quality of Life Assessment at Forty-Two Days | Evaluated quality of life changes from baseline to end-of-treatment to 3.5-month follow up using the Harvard Flourishing Measure. Life Satisfaction (Items 1-2) ranges from 0 = Not Satisfied at All, 10 = Completely Satisfied, Mental and Physical Health (3-4) ranges from 0 = Poor, 10 = Excellent, Meaning and Purpose (5-6) ranges from 0 = Not at All Worthwhile, 10 = Completely Worthwhile and 0 = Strongly Disagree, 10 = Strongly Agree, Character and Virtue (7-8) ranges from 0 = Not True of Me, 10 = Completely True of Me, and Close Social Relationships (9-10) ranges from 0 = Strongly Disagree, 10 = Strongly Agree. A sixth domain, Financial and Material Stability (11-12) may be necessary to sustain the other domains over time ranges from 0 = Worry All of the Time, 10 = Do Not Ever Worry. . | At 42 days |
| Quality of Life Assessment at Ninety-Eight Days | Evaluated quality of life changes from baseline to end-of-treatment to 3.5-month follow up using the Harvard Flourishing Measure. Life Satisfaction (Items 1-2) ranges from 0 = Not Satisfied at All, 10 = Completely Satisfied, Mental and Physical Health (3-4) ranges from 0 = Poor, 10 = Excellent, Meaning and Purpose (5-6) ranges from 0 = Not at All Worthwhile, 10 = Completely Worthwhile and 0 = Strongly Disagree, 10 = Strongly Agree, Character and Virtue (7-8) ranges from 0 = Not True of Me, 10 = Completely True of Me, and Close Social Relationships (9-10) ranges from 0 = Strongly Disagree, 10 = Strongly Agree. A sixth domain, Financial and Material Stability (11-12) may be necessary to sustain the other domains over time ranges from 0 = Worry All of the Time, 10 = Do Not Ever Worry. | At 98 days |
| Caregiver strain at Forty-Two Days | The Measured by the Modified Caregiver Strain Index is a 13-item tool measuring strain related to care provision with at least one item for each of the following major domains: financial, physical, psychological, social, and personal. The instrument is used to assess individuals of any age who assume the role of care giving.The index ranges from: Yes, On a Regular Basis=2, Yes, Sometimes =1, and No=0. | At 42 days |
| Caregiver strain at Ninety-Eight Days | The Measured by the Modified Caregiver Strain Index is a 13-item tool measuring strain related to care provision with at least one item for each of the following major domains: financial, physical, psychological, social, and personal. The instrument is used to assess individuals of any age who assume the role of care giving.The index ranges from: Yes, On a Regular Basis=2, Yes, Sometimes =1, and No=0. | At 98 days |
| Impact of pain intensity and interference with catastrophizing through rumination, helplessness, and pessimism at Forty-Two Days | Evaluated using the Pain Catastrophizing Scale. Where 0=Not at all, 1=To a slight degree, 2=To a moderate degree, 3=To a great degree, 4= All the time. | At 42 days |
| Impact of pain intensity and interference with catastrophizing through rumination, helplessness, and pessimism at Ninety-Eight Days | Evaluated using the Pain Catastrophizing Scale. Where 0=Not at all, 1=To a slight degree, 2=To a moderate degree, 3=To a great degree, 4= All the time. | At 98 days |
| Religious and spiritual assessment at Forty-Two Days | Evaluated using Santa Clara Strength of Religious Faith Questionnaire. 1 = strongly disagree, 2 = disagree, 3 = agree and 4 = strongly agree. | At 42 days |
| Religious and spiritual assessment at Ninety-Eight Days | Evaluated using Santa Clara Strength of Religious Faith Questionnaire. 1 = strongly disagree, 2 = disagree, 3 = agree and 4 = strongly agree. | At 98 days |
| Social connectedness at Forty-Two Days | Evaluated using the Social Connectedness Scale-Revised. The Social Connectedness Scale-Revised is a validated 8-item self-report measure assessing the degree to which subjects feel socially connected as a psychological sense of belonging. Where 1= Strongly Disagree, 2= Disagree, 3=Mildly Disagree, 4= Mildly Agree, 5= Agree, 6= Strongly Agree | At 42 days |
| Social connectedness at Ninety-Eight Days | Evaluated using the Social Connectedness Scale-Revised. The Social Connectedness Scale-Revised is a validated 8-item self-report measure assessing the degree to which subjects feel socially connected as a psychological sense of belonging. Where 1= Strongly Disagree, 2= Disagree, 3=Mildly Disagree, 4= Mildly Agree, 5= Agree, 6= Strongly Agree | At 98 days |
| Self-reported opioid use in the form of oral morphine equivalents over past week at Forty-Two Days | Opioid use in the form of oral morphine equivalents. | At 42 days |
| Self-reported opioid use in the form of oral morphine equivalents over past week at Ninety-Eight Days | Opioid use in the form of oral morphine equivalents. | At 98 days |
| Self-reported polypharmacy over past week at Forty-Two Days | The number of total medications used to manage physical and emotional symptoms | At 42 days |
| Self-reported polypharmacy over past week | The number of total medications used to manage physical and emotional symptoms | At 98 days |
| Global psychosocial functioning (participant and caregiver) at Forty-Two Days | Evaluated using using the Work and Social Adjustment Scale. It is a 5-item measure of general social impairment, and specifically their ability to function in terms of work, tasks at home, social leisure, private leisure, and personal or family relationships. Score: 0-9= low impairment, 10-19= moderate impairment, 20-40 severe impairment. | At 42 days |
| Global psychosocial functioning (participant and caregiver) at Ninety-Eight Days | Evaluated using using the Work and Social Adjustment Scale. It is a 5-item measure of general social impairment, and specifically their ability to function in terms of work, tasks at home, social leisure, private leisure, and personal or family relationships. Score: 0-9= low impairment, 10-19= moderate impairment, 20-40 severe impairment. | At 98 days |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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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