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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030078
Receipt No. R000034339
Scientific Title Palliative care research as a whole person approach in comprehensive medical care internal medicine
Date of disclosure of the study information 2017/11/22
Last modified on 2018/08/22

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Basic information
Public title Palliative care research as a whole person approach in comprehensive medical care internal medicine
Acronym Palliative care by comprehensive internal medicine
Scientific Title Palliative care research as a whole person approach in comprehensive medical care internal medicine
Scientific Title:Acronym Palliative care by comprehensive internal medicine
Region
Japan

Condition
Condition General medical disorder at the terminal stage
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Hematology and clinical oncology
Geriatrics Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Symptomatic relief and mental stability
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Symptom control score
Evaluation every 2 weeks
Key secondary outcomes Questionnaire survey on spiritual stability of the person and family

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consent from the patient or family
Key exclusion criteria Did not obtain consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Noguchi
Organization saitama medical university
Division name Department of General Internal Medicine
Zip code
Address 38 Morohongo Moroyama-machi Iruma-gun Saitama, Japan
TEL 049-276-1667
Email guchan@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Noguchi
Organization Saitama Medical University
Division name Department of General Internal Medicine
Zip code
Address 38 Morohongo Moroyama-machi Iruma-gun Saitama, Japan
TEL 049-276-1111
Homepage URL
Email guchan@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Department of General Internal Medicine
Institute
Department

Funding Source
Organization Saitama Medical University
Department of General Internal Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 埼玉医科大学病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patient satisfaction is high due to intervention of palliative care team on symptom control of terminal chronic disease.

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2018 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034339

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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