UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009768 |
|---|---|
| Receipt number | 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 | 2023/02/25 10:10:22 |
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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 | 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
055-989-5222
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
055-989-5222
Homepage URL
t.naito@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
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
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
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
| 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
30
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
| 2013 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 23 | Day |
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
| 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=R000011444
| 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 |
