UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030078
Receipt number 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 2020/02/21 20:53:26

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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

100 years-old >=

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 Toru
Middle name
Last name Noguchi

Organization

saitama medical university

Division name

Department of General Internal Medicine

Zip code

350-0495

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 Toru
Middle name
Last name Noguchi

Organization

Saitama Medical University

Division name

Department of General Internal Medicine

Zip code

350-0495

Address

38 Morohongo Moroyama-machi Iruma-gun Saitama, Japan

TEL

049-276-1111

Homepage URL


Email

guchan@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University
Department of General Internal Medicine

Institute

Department

Personal name



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

Institutional Review Board in Saitama medical university hospital

Address

38 Morohongo Moroyama-machi Iruma-gun Saitama, Japan

Tel

049-276-1354

Email

049-276-1354


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

Completed

Date of protocol fixation

2017 Year 12 Month 04 Day

Date of IRB

2017 Year 12 Month 04 Day

Anticipated trial start date

2017 Year 12 Month 04 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 04 Month 30 Day


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

2020 Year 02 Month 21 Day



Link to view the page

Value
https://center6.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