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
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
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
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
