RESTORE
Randomized phasE II Study for Efficacy of healThcare prOvider's REcommened Communication With Sympathy in Terminally Ill Cancer Patients Treated With Palliative Sedation
Sponsor study identifier
interventional
62
1 country
1
Study Start
November 1, 2020
Actual (reported)Primary Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2020
Actual (reported)November 22, 2020
Actual (reported)November 24, 2020
Actual (reported)November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Satisfaction of caregiver
2th to 7th day after enrollment
Anxiety of caregiver
2th to 7th day after enrollment
Palliative sedation related Adverse events
From date of enrollment until death or discharge/transfer, assess up to 2 years
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).
Patients and caregivers were received palliative sedation without intervention.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pusan National University Yangsan Hospital
Yangsan, South Korea
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.
Kwonoh Park, MD, phD
Pusan National University Yangsan Hospital
First Submitted
November 22, 2020
First Posted
November 24, 2020
Study Start
November 1, 2020
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
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.
November 30, 2022
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 2, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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