UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007607 |
|---|---|
| Receipt number | 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 11:36:02 |
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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
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
hatta1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008955
