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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013171
Receipt No. R000015359
Scientific Title Prospective observational study of hospitalization associated disability in the elderly patients living with advanced non-small cell lung cancer.
Date of disclosure of the study information 2014/02/17
Last modified on 2021/02/23

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Basic information
Public title Prospective observational study of hospitalization associated disability in the elderly patients living with advanced non-small cell lung cancer.
Acronym Hospitalization associated disability in elderly patients with NSCLC
Scientific Title Prospective observational study of hospitalization associated disability in the elderly patients living with advanced non-small cell lung cancer.
Scientific Title:Acronym Hospitalization associated disability in elderly patients with NSCLC
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the risk-factors of hospitalization associated disability (HAD) in the elderly NSCLC patients receiving chemotherapy.
Basic objectives2 Others
Basic objectives -Others To elucidate the association between HAD and changes in physical activity, lifestyle, and QOL.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in Barthel Index in each period of hospitalization.
Key secondary outcomes Changes in lifestyle, physical activity, health related QOL, and Barthel Index during the follow-up period.

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 Tateaki
Middle name
Last name Tateaki Naito
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code 411-8777
Address 1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL 0559895222
Email t.naito@scchr.jp

Public contact
Name of contact person
1st name Tateaki
Middle name
Last name Naito
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
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 Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Shizuoka Cancer Center
Address 1007 Shimonagakubo, Nagaizumi, Sunto, Shizuoka
Tel 0559895222
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 17 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 33
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 Completed
Date of protocol fixation
2014 Year 02 Month 07 Day
Date of IRB
2014 Year 02 Month 17 Day
Anticipated trial start date
2014 Year 02 Month 17 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. accelerometer (Lifecorder-GS)
2. Barthel Index
3. EORTC-C30 and EQ-5D
4. Lifestyle questionnaire

Management information
Registered date
2014 Year 02 Month 15 Day
Last modified on
2021 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015359

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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