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

October 31, 2021 updated by: Kwonoh Park, MD phD, Pusan National University Yangsan Hospital

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

  • 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Yangsan, Korea, Republic of
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of enrollment until death or discharge/transfer, assess up to 2 years
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
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
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")
2th to 7th day after enrollment
Anxiety of caregiver
Time Frame: 2th to 7th day after enrollment
GAD-7 (General Anxiety Disorder-7)
2th to 7th day after enrollment
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
From date of enrollment until death or discharge/transfer, assess up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

November 30, 2022

Study Completion (ANTICIPATED)

November 30, 2022

Study Registration Dates

First Submitted

November 22, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (ACTUAL)

November 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 31, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RESTORE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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