NCT04642677UnknownPhase 2
Randomized phasE II Study for Efficacy of healThcare prOvider's REcommened Communication With Sympathy in Terminally Ill Cancer Patients Treated With Palliative Sedation
Pusan National University Yangsan Hospital1 site in 1 country62 target enrollmentStarted: November 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Complete response rate of palliative sedation
Study Overview
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."
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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)
Investigators
Kwonoh Park, MD phD
Assistant professor
Pusan National University Yangsan Hospital
Study Sites (1)
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