UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025457
Receipt number R000029294
Scientific Title Multicenter prospective observational study to elucidate the dying process
Date of disclosure of the study information 2017/01/01
Last modified on 2020/07/01 11:18:19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Multicenter prospective observational study to elucidate the dying process

Acronym

EASED

Scientific Title

Multicenter prospective observational study to elucidate the dying process

Scientific Title:Acronym

EASED

Region

Japan


Condition

Condition

Cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the dying process and end-of-life care in terminally-ill cancer patients admitted to palliative care units

Basic objectives2

Others

Basic objectives -Others

To develop a prognostic scale of dying within 3 days and within 1 day after Palliatie Performance Scale (PPS) </=20% in terminally-ill cancer patients admitted to palliative care units.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Impending death signs after PPS</=20%

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) patients of age 18 or older
2) patients with locally advanced or metastatic cancer (histological, cytological, or clinical diagnosis)
3) patients admitted to the participating Palliative care units

Key exclusion criteria

1) patients with scheduled discharge within a week
2) patients or their families who decline participation.

Target sample size

1600


Research contact person

Name of lead principal investigator

1st name Masanori
Middle name
Last name Mori

Organization

Seirei Mikatahara General Hospital

Division name

Palliative and Supportive Care Division

Zip code

433-8558

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka, Japan, 433-8558

TEL

053-436-1251

Email

glacemori@hotmail.com


Public contact

Name of contact person

1st name Masanori
Middle name
Last name Mori

Organization

Seirei Mikatahara General Hospital

Division name

Palliative and Supportive Care Division

Zip code

433-8558

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka, Japan, 433-8558

TEL

053-436-1251

Homepage URL


Email

glacemori@hotmail.com


Sponsor or person

Institute

Seirei Mikatahara General Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Seirei Mikatahara General Hospital

Address

3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka, Japan, 433-8558

Tel

053-436-1251

Email

mk-rinri@sis.seirei.or.jp


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

2017 Year 01 Month 01 Day


Related information

URL releasing protocol

Not applicable

Publication of results

Unpublished


Result

URL related to results and publications

Not applicable

Number of participants that the trial has enrolled

1896

Results

Under analysis of data of a total of 1896 participants.

Results date posted

2020 Year 07 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Under analysis

Participant flow

Under analysis

Adverse events

Under analysis

Outcome measures

Under analysis

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2016 Year 07 Month 14 Day

Date of IRB

2016 Year 07 Month 25 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information

Under analysis


Management information

Registered date

2016 Year 12 Month 28 Day

Last modified on

2020 Year 07 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029294


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name