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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009768
Receipt No. R000011444
Scientific Title Prospective observational study of functional decline and disabilities in the elderly living with lung cancer.
Date of disclosure of the study information 2013/01/14
Last modified on 2018/02/17

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Basic information
Public title Prospective observational study of functional decline and disabilities
in the elderly living with lung cancer.
Acronym Disabilities in the elderly living with lung cancer
Scientific Title Prospective observational study of functional decline and disabilities
in the elderly living with lung cancer.
Scientific Title:Acronym Disabilities in the elderly living with lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess changes in ADL and physical function over time for elderly with non-small cell lung cancer receiving anti-cancer treatment.
Basic objectives2 Others
Basic objectives -Others To find cadidates for rehabilitational intervention during anti-cancer treatment.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of patients with physical functional decline or disabilities after 4 to 8 weeks after initiating chemotherapy.
Key secondary outcomes The proportion of patients with physical functional decline or disabilities after 12 and 24 weeks 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 0) Groups
group 1: Patients receiving chemotherapy (n=30)
group 2: Patients receiving radiotherapy (n=30)

1) >=70 years old
2) Non-small cell lung cancer in stage III , IV, or post-operative relapse.
3) They planned to receive the first anti-cancer treatment including radiotherapy, chemotherapy, or chemoradiotherapy.
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 1) They can not be done a physical assessment.
2) Having symptomatic brain metastasis.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tateaki Naito
Organization Shizuoka Cancer Center
Division name Division of thoracic oncology
Zip code
Address 1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL 055-989-5222
Email t.naito@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tateaki Naito
Organization Shizuoka Cancer Center
Division name Division of thoracic oncology
Zip code
Address 1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL 055-989-5222
Homepage URL
Email t.naito@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://bmccancer.biomedcentral.com/articles/10.1186/s12885-017-3562-4
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 Main results already published
Date of protocol fixation
2013 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Cancer functional assessment set
2. Shuttle walking test
3. Barthel Index
4. Body composition
5. Mini nutritional assessment
6. MMSE

Management information
Registered date
2013 Year 01 Month 13 Day
Last modified on
2018 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011444

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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