UMIN-CTR Clinical Trial

Recruitment status Completed
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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.


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


In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.


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 or person

Institute

Translational Research Center, Kyoto University Hospital

Institute

Department

Personal name


Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean "funding agency". Therefore, all clinical trial should have the one.


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001955