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 |
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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
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
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
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
