UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012845
Receipt number 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 19:19:16

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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 or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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