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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 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). |
|
| Group B | No Intervention | Patients and caregivers were received palliative sedation without intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| healthcare provider's recommended communication with sympathy and printed paper | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Discontinuation rate of palliative sedation irrespective of physician | Rate of cases (caregiver's refuse or others) among all causes (death, multi-organ failure, failure of sedation level, palliative sedation related adverse events, caregiver's refuse, or others) as discontinuation causes of palliative sedation | From date of enrollment until death or discharge/transfer, assess up to 2 years |
| Complete response rate of palliative sedation | Rate of cases (death or multiogran failure) among all causes (death, multi-organ failure, failure of sedation level, palliative sedation related adverse events, caregiver's refuse, or others) as discontinuation causes of palliative sedation | From date of enrollment until death or discharge/transfer, assess up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of caregiver | How is your satisfaction with the IV access so far?" (rated as "much comfort", "a little comfort", "no change", "a little discomfort", or "much discomfort") | 2th to 7th day after enrollment |
| Anxiety of caregiver |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kwonoh Park, MD, phD | Contact | 821033783529 | parkkoh@daum.net |
| Name | Affiliation | Role |
|---|---|---|
| Kwonoh Park, MD, phD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23666472 | Result | 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. | |
| 28192224 | Result | 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. |
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Prospective, Single institution, Open-label, Randomized, Phase 2
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|
GAD-7 (General Anxiety Disorder-7)
| 2th to 7th day after enrollment |
| Palliative sedation related Adverse events | Adverse events related with palliative sedation using CTCAE 4.3 | From date of enrollment until death or discharge/transfer, assess up to 2 years |
| 22959227 | Result | 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. |
| 22412129 | Result | 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. |
| 24647491 | Result | 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. |
| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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