Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress (KAPTIVATED)
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ClinicalTrials.gov Identifier: NCT05344625 |
Recruitment Status :
Withdrawn
(Study team is not moving forward with protocol)
First Posted : April 25, 2022
Last Update Posted : January 24, 2024
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Sponsor:
Northwell Health
Information provided by (Responsible Party):
Northwell Health
Tracking Information | |||||||
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First Submitted Date ICMJE | March 31, 2022 | ||||||
First Posted Date ICMJE | April 25, 2022 | ||||||
Last Update Posted Date | January 24, 2024 | ||||||
Actual Study Start Date ICMJE | October 31, 2023 | ||||||
Estimated Primary Completion Date | March 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Percentage of population completing at least one KAP session. [ Time Frame: Within 6 months from completion of radiation therapy ] The percentage of subjects who complete at least 1 session of KAP will be calculated, along with the associated 95% exact binomial confidence interval. The null hypothesis will be rejective if >50% of patients complete at least 1 KAP session.
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Original Primary Outcome Measures ICMJE |
Feasibility of Ketamine Assisted Psychotherapy in the palliative radiation population [ Time Frame: Within 3 months from completion of radiation therapy ] The percentage of subjects who complete at least 1 session of KAP will be calculated, along with the associated 95% exact binomial confidence interval. The null hypothesis will be rejective if >50% of patients complete at least 1 KAP session.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress | ||||||
Official Title ICMJE | Ketamine-Assisted Psychotherapy Viability in Treating Cancer-Related Emotional Distress | ||||||
Brief Summary | The present study will investigate if ketamine-assisted psychotherapy during palliative radiation therapy is safe, feasible, and effective at reducing psychological distress. | ||||||
Detailed Description | Patients prescribed palliative radiation therapy with moderate-severe cancer-related anxiety or depression will be prescribed 3 Ketamine Assisted Psychotherapy (KAP) sessions. At the time of enrollment, they will complete surveys to assess depression, anxiety, and existential distress. KAP will be preceded by a preparatory session during which the subjects will virtually meet their the KAP clinical team, discuss important stressors or concerns, and prepare for KAP. Each KAP session will last approximately 3 hours during which patients will receive an individualized dose of Ketalar intramuscularly, and after the ketamine experience subsides, the patient will discuss the experience with a psychotherapist trained in KAP. A virtual integration session will occur the day after each KAP session as it provides patients with an opportunity to work collaboratively with their assigned therapist in a manner that can help translate any insights from their preparation and KAP sessions into actionable goals. Depression, anxiety, and existential distress will be measured throughout the trial to assess the impact from KAP. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Early Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Ketamine 100 MG/ML
Ketamine Assisted Psychotherapy
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Study Arms ICMJE | Experimental: Ketamine Assisted Psychotherapy
3 KAP sessions lasting approximately 3 hours using less than or equal to 60mg or 1mg/kg of intramuscular Ketalar as the facilitating chemical. KAP sessions will be supplemented with integration sessions occurring the following day and 1 month after the final KAP session.
Intervention: Drug: Ketamine 100 MG/ML
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Withdrawn | ||||||
Actual Enrollment ICMJE |
0 | ||||||
Original Estimated Enrollment ICMJE |
15 | ||||||
Estimated Study Completion Date ICMJE | March 15, 2024 | ||||||
Estimated Primary Completion Date | March 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05344625 | ||||||
Other Study ID Numbers ICMJE | 22-0418 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Northwell Health | ||||||
Original Responsible Party | Bhupesh Parashar, MD, Northwell Health, Professor | ||||||
Current Study Sponsor ICMJE | Northwell Health | ||||||
Original Study Sponsor ICMJE | Bhupesh Parashar, MD | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Northwell Health | ||||||
Verification Date | January 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |