UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017604 |
|---|---|
| Receipt number | 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 13:41:58 |
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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
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
ichimura@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Hitachi Medical Education and Research Center, University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020405
