Clinical trial NCT04642677: REcommened Communication With Sympathy in Terminally Ill Cancer Patients Treated With Palliative Sedation
Official title: Randomized phasE II Study for Efficacy of healThcare prOvider's REcommened Communication With Sympathy in Terminally Ill Cancer Patients Treated With Palliative Sedation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Communication, Palliative Sedation
Keywords: Communication, Palliative sedation
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Single institution, Open-label, Randomized, Phase 2
Primary purpose: TREATMENT

Brief summary: * In terminally ill cancer patients, palliative sedation has been applied to intractable refractory symptoms such as pain, dyspnea, delirium, agitation.
* Palliative sedation is generally an adaptive strategies using midazolam, which is composed of intermittent bolus, limited continuous, or 24hr continuous infusion depending on the time of drug application.
* In the application of palliative sedation, caregiver's negative feelings such as anxiety or guilt for palliative sufficiency are one of the biggest challenges as the patient's consciousness is reduced, and they feels disconnected from the patient.
* In general, hearing is known to persist until the very last moment of the end of life, regardless of consciousness. In addition, maintaining communication with patients and caregivers is the most important part of the hospice.
* This study evaluate the efficacy of healthcare provider's recommended communication with sympathy, "Regardless of the patient's outward consciousness, talk with the patient and express empathy. Hearing will be maintained until the end."


Eligibility criteria: Inclusion Criteria:

* Patients who are expected to die within a few weeks due to disease progression without additional anti-tumor treatment plans.
* Patients who are the target of palliative sedation because intractable symptom such as pain, dyspnea, delirium, or agitation persist as even after the conservative treatment.
* Patients who have agreed to palliative sedation.

Exclusion Criteria:

* Patients treated with a palliative sedation methods using bolus application or other drugs (lorazepam, etc.) rather than continuous midazolam were excluded.
* In case of the guardian is unable to stay with the patient for more than 6 hours per day, the patients were excluded.

Primary outcomes:
measure: Discontinuation rate of palliative sedation irrespective of physician
timeFrame: From date of enrollment until death or discharge/transfer, assess up to 2 years
measure: Complete response rate of palliative sedation
timeFrame: From date of enrollment until death or discharge/transfer, assess up to 2 years
Secondary outcomes:
measure: Satisfaction of caregiver
timeFrame: 2th to 7th day after enrollment
measure: Anxiety of caregiver
timeFrame: 2th to 7th day after enrollment
measure: Palliative sedation related Adverse events
timeFrame: From date of enrollment until death or discharge/transfer, assess up to 2 years
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Kwonoh Park, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maltoni M, Scarpi E, Nanni O. Palliative sedation in end-of-life care. Curr Opin Oncol. 2013 Jul;25(4):360-7. doi: 10.1097/CCO.0b013e3283622c47.
citation: Eun Y, Hong IW, Bruera E, Kang JH. Qualitative Study on the Perceptions of Terminally Ill Cancer Patients and Their Family Members Regarding End-of-Life Experiences Focusing on Palliative Sedation. J Pain Symptom Manage. 2017 Jun;53(6):1010-1016. doi: 10.1016/j.jpainsymman.2016.12.353. Epub 2017 Feb 10.
citation: Kang JH, Shin SH, Bruera E. Comprehensive approaches to managing delirium in patients with advanced cancer. Cancer Treat Rev. 2013 Feb;39(1):105-12. doi: 10.1016/j.ctrv.2012.08.001. Epub 2012 Sep 6.
citation: Maltoni M, Scarpi E, Rosati M, Derni S, Fabbri L, Martini F, Amadori D, Nanni O. Palliative sedation in end-of-life care and survival: a systematic review. J Clin Oncol. 2012 Apr 20;30(12):1378-83. doi: 10.1200/JCO.2011.37.3795. Epub 2012 Mar 12.
citation: Papavasiliou EE, Payne S, Brearley S; EUROIMPACT. Current debates on end-of-life sedation: an international expert elicitation study. Support Care Cancer. 2014 Aug;22(8):2141-9. doi: 10.1007/s00520-014-2200-9. Epub 2014 Mar 20.