UMIN-CTR Clinical Trial

Basic information
Public title	Patient-reported health-related QOL assessment in patients underwent lung resection for lung cancer in mid-term and long-term period (Cross-sectional two-institutional study)
Acronym	Cross-sectional QOL assessment in patients underwent lung resection for lung cancer
Scientific Title	Patient-reported health-related QOL assessment in patients underwent lung resection for lung cancer in mid-term and long-term period (Cross-sectional two-institutional study)
Scientific Title:Acronym	Cross-sectional QOL assessment in patients underwent lung resection for lung cancer
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess patient-reported, health-related QOL in patients underwent lung resection for lung cancer in mid-term and long-term period cross-sectinally.
Basic objectives2	Others
Basic objectives -Others	To clarify the effect of surgical approach, an extent of lung resection, and other clinico-pathological factors on QOL.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	raw scores of each QOL questionnaire (EQ5D-5L, EORTC-QLQ-C30/LC13), Utility value and VAS value of EQ5D-5L.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
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Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patients underwent lung resection for lung cancer between Apr. 2009 and Mar. 2013., 2) patients without relapse or history of treatment for metachronous lung cancer, 3) patients underwent the surgery and followed up postoperatively at the identical hospital.
Key exclusion criteria	1)reading disability of Japanese, 2)severe visual disorder, 3)cognitive impairment or impairment of decision-making ability, 4) multiple primary cancer of other organ requiring major surgery, 5) disease or injury deteriorating QOL significantly.
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideo Ichimura
Organization	Hitachi Medical Education and Research Center, University of Tsukuba
Division name	Department of Thoracic Surgery
Zip code
Address	2-1-1 Jyounan, Hitachi, Ibaraki, Japan
TEL	+81-294-23-1111
Email	ichimura@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideo Ichimura
Organization	Hitachi Medical Education and Research Center, University of Tsukuba
Division name	Department of Thoracic Surgery
Zip code
Address	2-1-1 Jyounan, Hitachi, Ibaraki, Japan
TEL	+81-294-23-1111
Homepage URL
Email	ichimura@md.tsukuba.ac.jp

Sponsor
Institute	Department of Thoracic Surgery, Hitachi Medical Education and Research Center, University of Tsukuba
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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Address
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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	2015 Year 05 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Cross-sectional two-institutional study, In patients fulfilling the criteria, the QOL questionnaire including EQ5D-5L and EORTC-QLQ-C30/LC13 is sent by mail. Mid-term is defined as a period between postoperative 2 and 4 years. Long-term is defined as a period between postoperative 4 and 6 years. In each mid-term and long-term group, analyses how following factors influence on the QOL, 1)surgical approach, 2)an extent of lung resection, 3)other clinic-pathological factors and social factors.

Management information
Registered date	2015 Year 05 Month 18 Day
Last modified on	2018 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020405

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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