UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000811
Receipt number R000000970
Scientific Title Needs Assessment of Palliative Care in Keio University Hospital -Needs among Patients and Medical professionals -
Date of disclosure of the study information 2007/08/29
Last modified on 2010/07/30 01:24:45

* 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

Needs Assessment of Palliative Care in Keio University Hospital -Needs among Patients and Medical professionals -

Acronym

Keio University Hospital - Needs Assesment of Palliative Care

Scientific Title

Needs Assessment of Palliative Care in Keio University Hospital -Needs among Patients and Medical professionals -

Scientific Title:Acronym

Keio University Hospital - Needs Assesment of Palliative Care

Region

Japan


Condition

Condition

All hospitalized patients, except pediactic, psychiatry, ophthalmology

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Psychosomatic Internal Medicine Infectious disease
Geriatrics Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Endocrine surgery Breast surgery Obstetrics and Gynecology
Dermatology Psychiatry Oto-rhino-laryngology
Orthopedics Urology Radiology
Anesthesiology Oral surgery Neurosurgery
Cardiovascular surgery Plastic surgery Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

1) To assess the needs of all the hospitalized patients with any diagnosis, any stage of illnesses in a university hospital
2) To assess the awareness of medical professionals in a university hospital

Basic objectives2

Others

Basic objectives -Others

To assess utilization rate of various palliave services

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

M D Anderson Symptom Inventory, Japanese version
Scale of Worry
Japanese version Hospital Anxiety and Depression Scale

Key secondary outcomes

Performance Status (ECOG)
Utilization Rate of Various Palliave Services
Performance Status (ECOG)


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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

All the hospitalized patients with written consent

Key exclusion criteria

Within seven days from any operation
Those recognized as insuitable for study by their doctor in charge

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Saori Hashiguchi

Organization

Keio University School of Medicine

Division name

Anestheology

Zip code


Address

35 Shinanomachi Shinjuku Tokyo

TEL

03-5363-3829

Email



Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Fujisawa

Organization

Keio University School of Medicine

Division name

Psychiatry

Zip code


Address

35 Shinanomachi Shinjuku Tokyo

TEL

03-5363-3829

Homepage URL


Email



Sponsor or person

Institute

Keio University Palliative Care Team

Institute

Department

Personal name



Funding Source

Organization

Keio University SFC

Organization

Division

Category of Funding Organization

Non profit foundation

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

2007 Year 08 Month 29 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2007 Year 08 Month 27 Day

Date of IRB


Anticipated trial start date

2007 Year 08 Month 01 Day

Last follow-up date

2007 Year 09 Month 01 Day

Date of closure to data entry

2007 Year 10 Month 01 Day

Date trial data considered complete

2007 Year 10 Month 01 Day

Date analysis concluded

2008 Year 12 Month 01 Day


Other

Other related information

Fujisawa D, Park S, Kimura R, Suyama I, Koyama Y, Takeuchi M, Yoshikawa H, Hashiguchi S, Shirahase J, Kato M, Takeda J, Kashima H.
Unmet supportive needs of cancer patients in an acute care hospital in Japan-a census study.
Support Care Cancer. 2009 Oct 21. [Epub ahead of print]
PMID: 19841949


Management information

Registered date

2007 Year 08 Month 29 Day

Last modified on

2010 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name