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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012845
Receipt No. R000014058
Scientific Title Prospective observational study of physical activity measured by accelerometer in the elderly living with advanced non-small cell lung cancer.
Date of disclosure of the study information 2014/01/15
Last modified on 2019/07/22

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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/ctr_e/ctr_view.cgi?recptno=R000014058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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