UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of physical activity measured by accelerometer in the elderly living with advanced non-small cell lung cancer.
Acronym	Physical Activity in Elderly with NSCLC
Scientific Title	Prospective observational study of physical activity measured by accelerometer in the elderly living with advanced non-small cell lung cancer.
Scientific Title:Acronym	Physical Activity in Elderly with NSCLC
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the changes in physical activity during chemotherapy for the elderly NSCLC patients.
Basic objectives2	Others
Basic objectives -Others	To reveal the risk factor for physical inactivcity and the association between physical activity and prognosis.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Change rate of daily step count during 6 months after initiating chmotherapy.
Key secondary outcomes	Change rate of moderate-to-vigorous physical activity during 6 months after initiating chemotherapy.

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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) >=70 years old 2) Non-small cell lung cancer in stage IV or post-operative relapse. 3) They planned to receive the chemotherapy. 4) ECOG-PS 0-2 5) Having written informed consent 6) They can be done physical assessment safely. 7) More than 12 weeks of survival was expected.
Key exclusion criteria	Those who have the risks for physical assessments including heart, bone, neurological, or psychological diseases.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Naito Middle name Last name Tateaki
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Zip code	411-8777
Address	1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL	+81-55-989-5222
Email	t.naito@scchr.jp

Public contact
Name of contact person	1st name Naito Middle name Last name Tateaki
Organization	Division of Thoracic Oncology
Division name	Thoracic Oncology Division
Zip code	411-8777
Address	1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL	+81-55-989-5222
Homepage URL
Email	t.naito@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Shizuoka Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Shizuoka Cancer Center
Address	1007 Shimonagakudo
Tel	055-989-5222
Email	t.naito@scchr.jp

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	静岡県立静岡がんセンター（静岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	http://www.apjon.org/preprintarticle.asp?id=233787
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	Enrolling by invitation
Date of protocol fixation	2013 Year 10 Month 13 Day
Date of IRB	2014 Year 01 Month 14 Day
Anticipated trial start date	2014 Year 01 Month 15 Day
Last follow-up date	2022 Year 02 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	On going trial

Management information
Registered date	2014 Year 01 Month 14 Day
Last modified on	2019 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014058