UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009162
Receipt number 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 17:34:50

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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 or person

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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