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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized phasE II Study for Efficacy of healThcare prOvider's REcommened Communication With Sympathy in Terminally Ill Cancer Patients Treated With Palliative Sedation

Conditions
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Communication, Palliative Sedation

Intervention / Treatment
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* Other: healthcare provider's recommended communication with sympathy and printed paper


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Single institution, Open-label, Randomized, Phase 2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* 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.<br>|
| No Intervention: Group B<br>Patients and caregivers were received palliative sedation without intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Communication, Palliative sedation