UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 09 Month 26 Day
Date of IRB	2018 Year 09 Month 26 Day
Anticipated trial start date	2019 Year 03 Month 22 Day
Last follow-up date	2019 Year 03 Month 22 Day
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	2019 Year 11 Month 22 Day

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