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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016522
Receipt No. R000019186
Scientific Title Survey of Medical Cost and Livelihood of CML Patients
Date of disclosure of the study information 2015/02/12
Last modified on 2015/11/30

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Basic information
Public title Survey of Medical Cost and Livelihood of CML Patients
Acronym Survey of Medical Cost and Livelihood of CML Patients
Scientific Title Survey of Medical Cost and Livelihood of CML Patients
Scientific Title:Acronym Survey of Medical Cost and Livelihood of CML Patients
Region
Japan

Condition
Condition CML
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation of burden and anxiety for the future of health care costs
Basic objectives2 Others
Basic objectives -Others Measurement of utility for CML patients
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Investigation of burden and anxiety for the future of health care costs
Key secondary outcomes QOL of CML patients, percentage of income and medical expenses, drug compliance

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) received medical treatment
(2) under drug therapy, or a drug treatment experience.
(3) received a description of the research
(4) more than three years from the start of treatment.
Key exclusion criteria (1) do not use of the high-cost medical care system.
(2) being welfare certification
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo OHASHI
Organization Chuo University
Division name Department of Integrated Science and Engineering for Sustainable Society
Zip code
Address Kasuga Bunkyo-ku TOKYO
TEL 03-3817-1715
Email ohashiy.00e@g.chuo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira NIWA
Organization Nonprofit Organization, Japan Clinical Research Support Unit
Division name Health Outcome Research Promotion Team
Zip code
Address Sotokanda Chiyoda-ku TOKYO
TEL 03-3254-8028
Homepage URL
Email niwa@crsu.org

Sponsor
Institute Nonprofit Organization, Japan Clinical Research Support Unit
Institute
Department

Funding Source
Organization Nonprofit Organization, TSUBASA
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 近畿大学(大阪府)、NTT東日本関東病院(東京都)、藤沢市民病院(神奈川県)、大阪市大(大阪府)、札幌北楡病院(北海道)、長崎大学(長崎県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 12 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 No longer recruiting
Date of protocol fixation
2014 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 12 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information Survey for CML Patients

Management information
Registered date
2015 Year 02 Month 12 Day
Last modified on
2015 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019186

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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