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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017604
Receipt No. R000020405
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)
Date of disclosure of the study information 2015/05/18
Last modified on 2018/09/22

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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
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) 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
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
2015 Year 05 Month 18 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 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
Registered date File name

Research case data
Registered date File name


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