UMIN-CTR Clinical Trial

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