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REcommened Communication With Sympathy in Terminally Ill Cancer Patients Treated With Palliative Sedation (RESTORE)

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ClinicalTrials.gov Identifier: NCT04642677
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Kwonoh Park, MD phD, Pusan National University Yangsan Hospital

Study Description
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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."

Condition or disease Intervention/treatment Phase
Communication, Palliative Sedation Other: healthcare provider's recommended communication with sympathy and printed paper Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Single institution, Open-label, Randomized, Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Other: 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.
No Intervention: Group B
Patients and caregivers were received palliative sedation without intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Discontinuation rate of palliative sedation irrespective of physician [ Time Frame: From date of enrollment until death or discharge/transfer, assess up to 2 years ]
    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

  2. Complete response rate of palliative sedation [ Time Frame: From date of enrollment until death or discharge/transfer, assess up to 2 years ]
    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


Secondary Outcome Measures :
  1. Satisfaction of caregiver [ Time Frame: 2th to 7th day after enrollment ]
    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")

  2. Anxiety of caregiver [ Time Frame: 2th to 7th day after enrollment ]
    GAD-7 (General Anxiety Disorder-7)

  3. Palliative sedation related Adverse events [ Time Frame: From date of enrollment until death or discharge/transfer, assess up to 2 years ]
    Adverse events related with palliative sedation using CTCAE 4.3


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642677


Contacts
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Contact: Kwonoh Park, MD, phD 821033783529 parkkoh@daum.net

Locations
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Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Contact: Kwonoh Park, MD, PhD    821033783529    parkkoh@daum.net   
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Kwonoh Park, MD, phD Pusan National University Yangsan Hospital
More Information
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Publications of Results:

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Responsible Party: Kwonoh Park, MD phD, Assistant professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT04642677    
Other Study ID Numbers: RESTORE
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kwonoh Park, MD phD, Pusan National University Yangsan Hospital:
Communication, Palliative sedation