UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037842 |
|---|---|
| Receipt number | R000043144 |
| Scientific Title | The effect of ACP for decision making : to decide cure place of elderly people with terminal cancer |
| Date of disclosure of the study information | 2019/08/29 |
| Last modified on | 2019/09/03 14:20:15 |
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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
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
research@hirose-hospital.com
Sponsor or person
Institute
Hirose Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043144
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
