UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048752 |
|---|---|
| Receipt number | R000055547 |
| Scientific Title | Association between objective prognostic prediction and physician willingness to implement advance care planning. A Randomised controlled trial. |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2022/08/25 11:38:14 |
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Basic information
Public title
Association between objective prognostic prediction and physician willingness to implement advance care planning. A Randomised controlled trial.
Acronym
Association between objective prognostic prediction and physician willingness to implement advance care planning. A Randomised controlled trial.
Scientific Title
Association between objective prognostic prediction and physician willingness to implement advance care planning. A Randomised controlled trial.
Scientific Title:Acronym
Association between objective prognostic prediction and physician willingness to implement advance care planning. A Randomised controlled trial.
Region
| Japan |
Condition
Condition
Neoplasms
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine whether physicians would be more motivated to introduce ACP if they were provided with a highly accurate prognosis using objective measures in addition to their subjective forecast (surprise question) 'I would not be surprised if this patient died within three months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Willingness to implement ACP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Providing accurate and objective prognosticationplus Surprise question
Interventions/Control_2
Surprise question only
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
| 24 | years-old | <= |
Age-upper limit
| 150 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Doctors treating at least one cancer patient per week
(2) Able to communicate in Japanese
(3) Written consent can be obtained.
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kizawa |
Organization
University of Tsukuba
Division name
Department of Palliative and Supportive Care, Faculty of Medicine,
Zip code
305-8575
Address
1-1-1, Tennoudai, Tsukuba, Ibaraki, JAPAN, 305-8575
TEL
029-853-3316
yoshikizawa@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kizawa |
Organization
University of Tsukuba
Division name
Department of Palliative and Supportive Care, Faculty of Medicine,
Zip code
305-8575
Address
1-1-1, Tennoudai, Tsukuba, Ibaraki, JAPAN, 305-8575
TEL
029-853-3316
Homepage URL
yoshikizawa@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba, Faculty of Medicine
Address
1-1-1, Tennoudai, Tsukuba, Ibaraki, JAPAN, 305-8575
Tel
029-853-3022
sien.ningenss@un.tsukuba.ac.jp
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
| 2022 | Year | 08 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055547
| 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 |
