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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034659
Receipt No. R000039514
Scientific Title Measurement of quality of life(QOL) in patients with solid cancer -The QOL research for developing a mapping algorithm -
Date of disclosure of the study information 2018/10/26
Last modified on 2018/11/12

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Basic information
Public title Measurement of quality of life(QOL) in patients with solid cancer
-The QOL research for developing a mapping algorithm -
Acronym QOL-MAC
Scientific Title Measurement of quality of life(QOL) in patients with solid cancer
-The QOL research for developing a mapping algorithm -
Scientific Title:Acronym QOL-MAC
Region
Japan

Condition
Condition Patients with lung, stomach, colorectal, breast, or other solid cancers
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Nephrology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Breast surgery
Obsterics and gynecology Oto-rhino-laryngology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 this study collects data with the aim of developing a mapping algorithm for converting QOL scores obtained from profiled QOL scales into QOL values
Basic objectives2 Others
Basic objectives -Others to collect data with the aim of developing a mapping algorithm for converting QOL scores obtained from profiled QOL scales into QOL values
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes this study collects data with the aim of developing a mapping algorithm for converting QOL scores obtained from profiled QOL scales into QOL values.
Key secondary outcomes

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 with advanced, metastatic, or recurrent disease who are eligible for the following criteria.
Eligibility criteria:

1)Patients with lung, stomach, colorectal, breast, or other solid cancers.
2)Patients treated with outpatient medication therapy, but hospitalized patients should be also included (about 10% of the total).
3)Patients aged 18 years or older with consent to this study.
4)Patients with PS 0 - 3 who can answer the questionnaire (including at least 25% of patients with PS 2 and over).
Key exclusion criteria 1)Patients unable to complete the questionnaires by themselves.
2)Patients with multiple cancers who are currently being treated.
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kojiro Shimozuma
Organization Ritsumeikan University
Division name College of Life Sciences, Department of Biomedical Sciences
Zip code
Address Noji-higashi 1-1-1, Kusatsu
TEL 077-561-3946
Email no@mail

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamao
Organization Public Health Research Foundation
Division name Comprehensive Support Project for Clinical Research(CSPOR)
Zip code
Address Nishi-Waseda1-1-7, Shinjuku-ku, Tokyo 169-0051, Japan
TEL 03-5287-2636
Homepage URL
Email cspor-office@csp.or.jp

Sponsor
Institute Public Health Research Foundation
Institute
Department

Funding Source
Organization National Institute of Public Health
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 10 Month 26 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2018 Year 10 Month 26 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039514

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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