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

Lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name