UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017594
Receipt number R000020392
Scientific Title Single-institutional Prospective QOL assessment in patients underwent lung resection for lung cancer
Date of disclosure of the study information 2015/05/16
Last modified on 2023/11/20 09:47:42

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Basic information

Public title

Single-institutional Prospective QOL assessment in patients underwent lung resection for lung cancer

Acronym

Prospective QOL assessment in patients underwent lung resection for lung cancer

Scientific Title

Single-institutional Prospective QOL assessment in patients underwent lung resection for lung cancer

Scientific Title:Acronym

Prospective 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 during perioperative, mid-term, long-term period.

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

patients who will undergo lung resection for lung cancer or who will undergo diagnostic surgery on suspicion of early lung cancer

Key exclusion criteria

1)reading disability of Japanese, 2)severe visual disorder, 3)cognitive impairment or impairment of decision-making ability, 4)pathological diagnosis except for lung cancer, 5)in the following cases, this longitudinal survey protocol will be terminated, i)postoperative relapse, ii)metachronous lung cancer, iii)multiple primary cancer of other organ requiring major surgery, iv)disease or injury deteriorating QOL significantly

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Hideo
Middle name
Last name Ichimura

Organization

Hitachi Medical Education and Research Center, University of Tsukuba

Division name

Department of Thoracic Surgery

Zip code

317-0077

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 Hideo
Middle name
Last name Ichimura

Organization

Hitachi Medical Education and Research Center, University of Tsukuba

Division name

Department of Thoracic Surgery

Zip code

317-0077

Address

2-1-1 Jyounan, Hitachi, Ibaraki, Japan

TEL

+81-294-23-1111

Homepage URL

http://www.hitachi.co.jp/hospital/hitachi/bumon/sinryouka/kokyuki_geka/index.html

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

The ethics review board of the hospital administration headquarters, Hitachi Ltd.

Address

2-1-1 Jyounan, Hitachi, Ibaraki

Tel

+81-294-23-1111

Email

webkanrisha.nichibyo.gd@hitachi.com


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 16 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/33508893, http://www.ncbi.nlm.nih.gov/pubmed/33608836

Number of participants that the trial has enrolled

279

Results

We conducted a prospective, single-center study of patient-reported outcomes (PRO) in lung cancer surgery and analyzed perioperative PRO including hospitalization, comparison of postoperative pain and subjective QOL between mini-thoracotomy approach and VATS approach, preoperative predictors of QOL one year posrtoperatively, and association between change in respiratory function and PRO. We have published the results in each paper.

Results date posted

2023 Year 11 Month 20 Day

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

Completed

Date of protocol fixation

2015 Year 03 Month 13 Day

Date of IRB

2015 Year 04 Month 07 Day

Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2023 Year 11 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective single-institutional study, In patients fulfilling the criteria, QOL survey will carry out using EQ5D-5L and EORTC-QLQ-C30/LC13. Survey is scheduled as follows; EQ5D-5L: preoperatively, on postoperative 1, 3, 5, 7-day, 1-month, 1, 3, 5-year. EORTC-QLQ-C30/LC13: preoperatively, on postoperative 1-month, 1, 3, 5-year.


Management information

Registered date

2015 Year 05 Month 15 Day

Last modified on

2023 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020392


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name