| Protocol ID | NCT05344625 |
| Registration Date | 2022-04-25 |
| Status | Withdrawn |
| Sponsor | Northwell Health |
| Country | – |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | – |
| Scope | – |
| First Patient In | 2023-10-31 |
| Last Patient Out | 2024-03-15 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 21 Years - 65 Years |
NCT05344625
Ketamine-Assisted Psychotherapy Viability in Treating Cancer-Related Emotional Distress
| Field |
CLAUDE
claude-sonnet-4-20250514 5302ms / 11865 tok |
OPENAI
gpt-4o 6230ms / 10186 tok |
GLM
glm-5.1 6327ms / 10354 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | yes | yes | yes | OK |
| intervention_complex | yes | yes | yes | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention being tested is ketamine-assisted psychotherapy (a drug plus psychotherapy), not palliative care consultation or service delivery - palliative care is the setting where this pharmacologic/psychological intervention is being studied.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is ketamine-assisted psychotherapy, not palliative care consultation or service delivery.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study tests Ketamine-Assisted Psychotherapy (a pharmacological/psychological intervention) in cancer patients receiving palliative radiation therapy, meaning palliative care is the setting, not the intervention itself.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — Virtual preparatory sessions and virtual integration sessions are core components of the ketamine-assisted psychotherapy intervention delivery model.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention includes virtual preparatory and integration sessions, which are central to the delivery of the ketamine-assisted psychotherapy, indicating that digital technology is a core delivery mechanism.
|
yes
no
shaky reasoning✓ Unanimous
Initial: no
|
OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | yes | yes | yes | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study includes feasibility metrics (percentage completing at least one KAP session) which are not covered by symptom/QoL/dignity/cost categories.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The primary outcome includes feasibility metrics for the completion of at least one KAP session, which is not covered by symptom/QoL/dignity/cost categories.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome measures feasibility (percentage of population completing a session) and the secondary outcomes include the Mystical Experience Questionnaire (MEQ-30), which does not fall under symptom, QoL, dignity, or cost categories.
|
OK |
| pharmacologic_sub | controlled substances | controlled substances | controlled substances | OK |