Communication, Palliative SedationPhase 2RESTORENCT04642677
REcommened Communication With Sympathy in Terminally Ill Cancer Patients Treated With Palliative Sedation
A Phase 2 study testing healthcare provider's recommended communication with sympathy and printed paper in people with Communication, Palliative Sedation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Palliative Sedation
- What is being tested?
- healthcare provider's recommended communication with sympathy and printed paper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2020to 30 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan
Kwonoh Park, MD, PhD, 821033783529, parkkoh@daum.net
About this study
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
- 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."
- Conditions
- Communication, Palliative Sedation
- Being tested
- healthcare provider's recommended communication with sympathy and printed paper
- Keywords
- Communication, Palliative sedation
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthcare provider's recommended communication with sympathy and printed paperOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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). Receives: Other: healthcare provider's recommended communication with sympathy and printed paper |
| Group B | No intervention | Patients and caregivers were received palliative sedation without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From date of enrollment until death or discharge/transfer, assess up to 2 years
Secondary outcomes (3)
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")
Measured: 2th to 7th day after enrollment
Anxiety of caregiver
GAD-7 (General Anxiety Disorder-7)
Measured: 2th to 7th day after enrollment
Palliative sedation related Adverse events
Adverse events related with palliative sedation using CTCAE 4.3
Measured: From date of enrollment until death or discharge/transfer, assess up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Nov 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Communication, Palliative SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Single institution, Open-label, Randomized, Phase 2
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwonoh Park, MD phD, Pusan National University Yangsan Hospital
- Investigators
- Kwonoh Park, MD, phD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642677
- Sponsor's protocol ID
- RESTORE
- Acronym
- RESTORE
- Status last verified
- Oct 2021
- First submitted
- 22 Nov 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Maltoni M, Scarpi E, Nanni O. Palliative sedation in end-of-life care. Curr Opin Oncol. 2013 Jul;25(4):360-7. doi: 10.1097/CCO.0b013e3283622c47.
PubMed 23666472Eun Y, Hong IW, Bruera E, Kang JH. Qualitative Study on the Perceptions of Terminally Ill Cancer Patients and Their Family Members Regarding End-of-Life Experiences Focusing on Palliative Sedation. J Pain Symptom Manage. 2017 Jun;53(6):1010-1016. doi: 10.1016/j.jpainsymman.2016.12.353. Epub 2017 Feb 10.
PubMed 28192224Kang JH, Shin SH, Bruera E. Comprehensive approaches to managing delirium in patients with advanced cancer. Cancer Treat Rev. 2013 Feb;39(1):105-12. doi: 10.1016/j.ctrv.2012.08.001. Epub 2012 Sep 6.
PubMed 22959227Maltoni M, Scarpi E, Rosati M, Derni S, Fabbri L, Martini F, Amadori D, Nanni O. Palliative sedation in end-of-life care and survival: a systematic review. J Clin Oncol. 2012 Apr 20;30(12):1378-83. doi: 10.1200/JCO.2011.37.3795. Epub 2012 Mar 12.
PubMed 22412129Papavasiliou EE, Payne S, Brearley S; EUROIMPACT. Current debates on end-of-life sedation: an international expert elicitation study. Support Care Cancer. 2014 Aug;22(8):2141-9. doi: 10.1007/s00520-014-2200-9. Epub 2014 Mar 20.
PubMed 24647491
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04642677
- Acronym / sponsor ID
- RESTORE / RESTORE
- Conditions
- Communication, Palliative Sedation
- Keywords
- Communication, Palliative sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Single institution, Open-label, Randomized, Phase 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: healthcare provider's recommended communication with sympathy and printed paperPatients 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). |
| Group B | No intervention | –Patients and caregivers were received palliative sedation without intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| healthcare provider's recommended communication with sympathy and printed paperPatients 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. | Other | Group A |
Primary outcome
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
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
3 secondary outcomes
Satisfaction of caregiver
Time frame: 2th to 7th day after enrollment
Anxiety of caregiver
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Results publication: PubMed 23666472Maltoni M, Scarpi E, Nanni O. Palliative sedation in end-of-life care. Curr Opin Oncol. 2013 Jul;25(4):360-7. doi: 10.1097/CCO.0b013e3283622c47.
- Results publication: PubMed 28192224Eun Y, Hong IW, Bruera E, Kang JH. Qualitative Study on the Perceptions of Terminally Ill Cancer Patients and Their Family Members Regarding End-of-Life Experiences Focusing on Palliative Sedation. J Pain Symptom Manage. 2017 Jun;53(6):1010-1016. doi: 10.1016/j.jpainsymman.2016.12.353. Epub 2017 Feb 10.
- Results publication: PubMed 22959227Kang JH, Shin SH, Bruera E. Comprehensive approaches to managing delirium in patients with advanced cancer. Cancer Treat Rev. 2013 Feb;39(1):105-12. doi: 10.1016/j.ctrv.2012.08.001. Epub 2012 Sep 6.
- Results publication: PubMed 22412129Maltoni M, Scarpi E, Rosati M, Derni S, Fabbri L, Martini F, Amadori D, Nanni O. Palliative sedation in end-of-life care and survival: a systematic review. J Clin Oncol. 2012 Apr 20;30(12):1378-83. doi: 10.1200/JCO.2011.37.3795. Epub 2012 Mar 12.
- Results publication: PubMed 24647491Papavasiliou EE, Payne S, Brearley S; EUROIMPACT. Current debates on end-of-life sedation: an international expert elicitation study. Support Care Cancer. 2014 Aug;22(8):2141-9. doi: 10.1007/s00520-014-2200-9. Epub 2014 Mar 20.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwonoh Park, MD, phD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing healthcare provider's recommended communication with sympathy and printed paper in people with Communication, Palliative Sedation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwonoh Park, MD, phD (821033783529, parkkoh@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discontinuation rate of palliative sedation irrespective of physician (time frame: From date of enrollment until death or discharge/transfer, assess up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642677, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.