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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009162
Receipt No. R000010749
Scientific Title The effectiveness of Liverpool Care Pathway Japanese version for the dying patients in general wards
Date of disclosure of the study information 2012/10/22
Last modified on 2013/04/25

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Basic information
Public title The effectiveness of Liverpool Care Pathway Japanese version for the dying patients in general wards
Acronym The effectiveness of LCP-J for the dying patients in general wards
Scientific Title The effectiveness of Liverpool Care Pathway Japanese version for the dying patients in general wards
Scientific Title:Acronym The effectiveness of LCP-J for the dying patients in general wards
Region
Japan

Condition
Condition Dying patients with malignancies
Classification by specialty
Pneumology Hematology and clinical oncology Nursing
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of Liverpool Care Pathway Japanese version for the dying patients in general wards by questionnaire surveys for nursing staff and bereaved family members, and by Medical-records survey
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the quality of care for the dying patients and after death by bereaved family members

Key secondary outcomes 1. To evaluate the quality of care for the dying patients and after death by nurse

2. To evaluate the treatments and examinations in last 48 hours


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1. Liverpool Care Pathway Japanese Version for the dying patients
2. a pamphlet for families of dying patients
3. a pamphlet for bereaved family members
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The cancer patient who is estimated to be if prognosis is within one week
Key exclusion criteria 1. Patient was not aware of the diagnosis of malignancy

2. The family does not receive explanation of Do Not Attempt Resuscitation

3. It is within one day for length of stay

4. The patient continues anticancer treatment(chemotherapy and radiation therapy, et al)

5. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsunori Miyashita
Organization Tohoku University Graduate School of Medicine
Division name Department of Palliative Nursing, Health Sciences
Zip code
Address 2-1 Seiryo-machi Aoba-ku Sendai, Miyagi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Kanno
Organization Tohoku University Graduate School of Medicine
Division name Department of Palliative Nursing, Health Sciences
Zip code
Address
TEL
Homepage URL
Email ykanno@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Challenging Exploratory Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 22 Day
Last modified on
2013 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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