UMIN-CTR Clinical Trial

Basic information
Public title	Relationship of physical function, physical activity, and QOL in non-small-cell lung cancer patients
Acronym	Physical function and physical activity in NSCLC patients
Scientific Title	Relationship of physical function, physical activity, and QOL in non-small-cell lung cancer patients
Scientific Title:Acronym	Physical function and physical activity in NSCLC patients
Region	Japan

Condition
Condition	Non-small-cell lung cancer
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purposes of the study is to investigate muscle strength, exercise capacity, physical activity, nutrition, and QOL in NSCLC patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	6 minute walk test, grip strength, knee extension strength, physical activity, balance function, QOL, nutrition, and QOL
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1. NSCLC patients have received adjuvant therapy in Niigata Cancer Center Hospital 2. Patients aged 20 years or more.
Key exclusion criteria	1. Patients have not received evaluation physical function due to muscle skeletal disease or cerebrovascular disease 2. Patients have not received evaluation the questionnaire due to psycho social disease 3. Physician have inappropriate for participation in research 4. Patients who did not obtain informed consent to this study
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Shinichiro Middle name Last name Morishita
Organization	Niigata University of Health and Welfare
Division name	Department of physical therapy
Zip code	950-3198
Address	Shimami-cho 1398, Kita-ku, Niigata City
TEL	0252574300
Email	morishita@nuhw.ac.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Morishita
Organization	Niigata University of Health and Welfare
Division name	Department of physical therapy
Zip code	950-3198
Address	Shimami-cho 1398, Kita-ku, Niigata City
TEL	0252574300
Homepage URL
Email	morishita@nuhw.ac.jp

Sponsor
Institute	Niigata University of Health and Welfare
Institute
Department

Funding Source
Organization	Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Niigata University of Health and Welfare
Address	Niigata University of Health and Welfare
Tel	025-257-4455
Email	kenshien@nuhw.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2017-65
Org. issuing International ID_1	Niigata Cancer Center Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 30 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	Suspended
Date of protocol fixation	2017 Year 10 Month 16 Day
Date of IRB	2017 Year 09 Month 04 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2020 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034002