REcommened Communication With Sympathy in Terminally Ill Cancer Patients Treated With Palliative Sedation
NCT ID: NCT04642677
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
62 participants
INTERVENTIONAL
2020-11-01
2022-11-30
Brief Summary
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* 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."
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Patients and caregivers were received palliative sedation with healthcare provider's recommended communication with sympathy and printed paper, "Regardless of the patient's outward consciousness, talk with the patient and express empathy. Hearing will be maintained until the end." three times a day (8, 14 and 20 o'clock).
healthcare provider's recommended communication with sympathy and printed paper
Patients and caregivers were received healthcare provider's recommended communication with sympathy and printed paper, "Regardless of the patient's outward consciousness, talk with the patient and express empathy. Hearing will be maintained until the end." three times a day (8, 14 and 20 o'clock) during palliative sedation.
Group B
Patients and caregivers were received palliative sedation without intervention.
No interventions assigned to this group
Interventions
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healthcare provider's recommended communication with sympathy and printed paper
Patients and caregivers were received healthcare provider's recommended communication with sympathy and printed paper, "Regardless of the patient's outward consciousness, talk with the patient and express empathy. Hearing will be maintained until the end." three times a day (8, 14 and 20 o'clock) during palliative sedation.
Eligibility Criteria
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Inclusion Criteria
* 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
* In case of the guardian is unable to stay with the patient for more than 6 hours per day, the patients were excluded.
18 Years
ALL
No
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Responsible Party
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Kwonoh Park, MD phD
Assistant professor
Principal Investigators
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Kwonoh Park, MD, phD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
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Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Kwonoh Park, MD, PhD
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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RESTORE
Identifier Type: -
Identifier Source: org_study_id