UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013171 |
|---|---|
| Receipt number | 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 | 2023/02/25 10:02:58 |
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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
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
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
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
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
| Delay expected |
Results Delay Reason
under review
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
| 2023 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015359
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
