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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Lung cancer | |
Classification by specialty |
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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 | |
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Randomization | |
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Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
Age-lower limit |
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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 |
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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 | ||||||
ichimura@md.tsukuba.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Results | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Terminated | ||||||
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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 |
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Last modified on |
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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 | |
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