UMIN-CTR Clinical Trial

Basic information
Public title	The effect of medical provider's dialogue: to decide treatment place of cancer elderly people
Acronym	The effect of medical provider's dialogue: to decide treatment place of cancer elderly people
Scientific Title	The effect of ACP for decision making : to decide cure place of elderly people with terminal cancer
Scientific Title:Acronym	The effect of ACP for terminal cancer elderly people
Region	Japan

Condition
Condition	Terminal cancer
Classification by specialty	Geriatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarlyfy the effect of ACP for decision making to decide cure place of elderly people who is terminal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ratio of death in own house
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Dialogue ACP Home visits care period 2-4 times/month 40 min./a visiting
Interventions/Control_2	Historical Control
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	60 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	1.New cancer patient of Hirose Hospital's home-based medicine, and historical control. 2.The patients of available dialogue with healthcare providers. 3.The patients of voluntary decision under informed consent.
Key exclusion criteria	1.The patients of unavailable with dialogue in first interview. 2.The participants in other clinical research past three months. 3.Inappropriate patient to particiate this study under the decision of PI.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name SHINICHIRO Middle name Last name SHIOZAWA
Organization	Hirose Hospital
Division name	Supporting Center for Clinical Research
Zip code	252-0105
Address	Kubosawa 2-3-16, Midoriku, Sagamihara city, Kanagawa, Japan
TEL	0427823021
Email	research@hirose-hospital.com

Public contact
Name of contact person	1st name SHINICHIRO Middle name Last name SHIOZAWA
Organization	Hirose Hospital
Division name	Supporting Center for Clinical Research
Zip code	252-0105
Address	Kubosawa 2-3-16, Midoriku, Sagamihara city, Kanagawa, Japan
TEL	0427823021
Homepage URL
Email	research@hirose-hospital.com

Sponsor
Institute	Hirose Hospital
Institute
Department

Funding Source
Organization	Hirose Hospital
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	MINS
Address	Dogenzaka 1-15-14 2F, Shibuyaku, Tokyo, Japan
Tel	0364161868
Email	npo-mins@j-irb.com

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	2019 Year 08 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2019 Year 05 Month 31 Day
Date of IRB	2019 Year 06 Month 03 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 29 Day
Last modified on	2019 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043144