UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008015 |
|---|---|
| Receipt number | R000009429 |
| Scientific Title | The study of factors affected the understanding informed consent |
| Date of disclosure of the study information | 2012/05/23 |
| Last modified on | 2012/11/26 10:00:46 |
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Basic information
Public title
The study of factors affected the understanding informed consent
Acronym
The study of factors affected the understanding informed consent
Scientific Title
The study of factors affected the understanding informed consent
Scientific Title:Acronym
The study of factors affected the understanding informed consent
Region
| Japan |
Condition
Condition
Advanced cancer patients
Classification by specialty
| Pneumology | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Asssessment of the capacity to consent to medical treatments
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution of assessment of the capacity to consent to medical treatments
: data from MacCAT-T
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interview for cancer patients who schedule chemotherapy for 20 minutes at a time
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Cancer patients who have histological diagnoses
2.Cancer patients who know their diseases
3.Cancer patients who concent to clinical research
4.Cancer patients who can read and write Japanese
Key exclusion criteria
1.Cancer patients who have severe physical condition and don't
endure interview study
2.Cancer patients who have severe mentalal condition and don't
endure interview study
3.Cancer patients who are regard to be
inappropriate participating this study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
National Cancer Center Hospital East
Research Center for Innovative Oncology
Division name
Psycho Oncology Division
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7134-7013
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cancer Center Hospital East
Division name
Psycho Oncology Division
Zip code
Address
TEL
04-7134-7013
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital East
Research Center for Innovative Oncology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 05 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 29 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 29 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 23 | Day |
Last modified on
| 2012 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009429
