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

Pusan National University Yangsan Hospital

Status and phase: Unknown; Phase 2

Conditions: Communication, Palliative Sedation

Treatments: Other: healthcare provider's recommended communication with sympathy and printed paper

Study type: Interventional

Funder types: Other

Identifiers

NCT04642677

RESTORE

Details and patient eligibility

About

• 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."

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Group A

Experimental group

Description:

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).

Treatment:

Other: healthcare provider's recommended communication with sympathy and printed paper

Group B

No Intervention group

Description:

Patients and caregivers were received palliative sedation without intervention.