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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007607
Receipt No. R000008955
Scientific Title Longitudinal study for observing the process of informed consent for outpatient chemotherapy
Date of disclosure of the study information 2012/04/20
Last modified on 2014/02/27

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Basic information
Public title Longitudinal study for observing the process of informed consent for outpatient chemotherapy
Acronym Mixed methods Observational Research during Informed Consent process for outpatient chemotherapy (MORE-IC) Act2
Scientific Title Longitudinal study for observing the process of informed consent for outpatient chemotherapy
Scientific Title:Acronym Mixed methods Observational Research during Informed Consent process for outpatient chemotherapy (MORE-IC) Act2
Region
Japan

Condition
Condition Lung Cancer, Breast Cancer
Classification by specialty
Pneumology Chest surgery Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To demonstrate how the cancer patients continue receiving chemotherapy and maintain their motivation, this study employed mixed-method approach.
Basic objectives2 Others
Basic objectives -Others Concrete aims:
1) examine the relationship among patient's concern about treatment, self-image, and subjective score for the process of informed consent,
2) conduct qualitative content analysis of the IC process, and describe how the physican-patient relationship emarge
3) reconfirm patient's interest about their treatment after the IC process,
4) quantify the patient's concern about treatment, and examine the change in their concern during chemotherapy,
5) make the data into longitudinal data set, and also process a cumulative case-study method.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Questionnaire of Achievement Motive for Medical Treatment.
Subjective score for process of informed consent.
Key secondary outcomes 1) scales regarding self-image.
2) observation record during the IC process, including audio-taped and transcribed data.

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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yokode Masayuki
Organization Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital
Division name Clinical Inovative Medicine
Zip code
Address 54 Shogoin-Kawaharacho, Kyoto 606-8507 JAPAN
TEL 075-751-4743
Email rinsho@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hatta Taichi
Organization Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital
Division name Clinical Inovative Medicine
Zip code
Address 54 Shogoin-Kawaharacho, Kyoto 606-8507 JAPAN
TEL 075-751-4739
Homepage URL http://www.kuhp.kyoto-u.ac.jp/~rinsho/more-ic/index.html
Email hatta1@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 20 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 Completed
Date of protocol fixation
2012 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 10 Month 01 Day
Date trial data considered complete
2013 Year 11 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information Exploratory observing the process of the IC for outpatient chemotherapy, using both qualitative and quantitative approach.

Management information
Registered date
2012 Year 03 Month 29 Day
Last modified on
2014 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008955

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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