UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001625 |
|---|---|
| Receipt number | R000001955 |
| Scientific Title | Observational study of the informed consent for outpatient chemotherapy - A multi-methods research using a questionnaire and an observational approach |
| Date of disclosure of the study information | 2009/01/10 |
| Last modified on | 2011/11/18 10:10:08 |
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Basic information
Public title
Observational study of the informed consent for outpatient chemotherapy
- A multi-methods research using a questionnaire and an observational approach
Acronym
Multi-methods Observational Research Employing both qualitative and quantitative approach for outpatient chemotherapy IC (MORE-IC)
Scientific Title
Observational study of the informed consent for outpatient chemotherapy
- A multi-methods research using a questionnaire and an observational approach
Scientific Title:Acronym
Multi-methods Observational Research Employing both qualitative and quantitative approach for outpatient chemotherapy IC (MORE-IC)
Region
| Japan |
Condition
Condition
Lung Cancer, Breast Cancer
Classification by specialty
| Chest surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the physician-patient interactions resulted from the IC about outpatient chemotherapy
Basic objectives2
Others
Basic objectives -Others
Collect the following data;
1) the questionnaire assessment to categorize patient's psychological state before IC
2) voice recording the IC for content analysis and generating categories
3) the subjective evaluation scores of IC, evaluated by physician and his patients respectively, numerically, and subjectively after IC
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The types of thematic units generated by content analysis of IC and the frequency of the categories
Key secondary outcomes
Co-relation between the following data;
1) the categories of patient's psychological state from questionnaire assessment before IC
2) the frequency of the categories generated by content analysis
3) the subjective evaluation scores after IC
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are enrolled in the study if they meet all of the following criteria
1) Written informed consent
2) They are 20 years old or older
3) Patients who are eligible for the study by their physicians
Key exclusion criteria
Patients who are disqualified the study by their physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yokode Masayuki |
Organization
Translational Research Center, Kyoto University Hospital
Division name
Clinical Inovative Medicine
Zip code
Address
54 Shogoin-Kawaharacho, Kyoto 606-8507 JAPAN
TEL
075-751-4743
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hatta Taichi |
Organization
Kyoto University Graduate School of Medicine
Division name
Clinical Inovative Medicine
Zip code
Address
54 Shogoin-Kawaharacho, Kyoto 606-8507 JAPAN
TEL
075-751-4739
Homepage URL
hatta1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Translational Research Center, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujiwara Memorial Foundation
Health Care Science Institute
Kyoto Cancer Society
Pfizer Health Research Foundation
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
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
| 2009 | Year | 01 | Month | 10 | 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
| 2008 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Exploratory observation of the IC for outpatient chemotherapy, using both qualitative and quantitative approach
Management information
Registered date
| 2009 | Year | 01 | Month | 07 | Day |
Last modified on
| 2011 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001955
