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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001625
Receipt No. 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

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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
Email

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
Email hatta1@kuhp.kyoto-u.ac.jp

Sponsor
Institute Translational Research Center, Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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