UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029762 |
|---|---|
| Receipt number | R000034002 |
| Scientific Title | Relationship of physical function, physical activity, and QOL in non-small-cell lung cancer patients |
| Date of disclosure of the study information | 2017/10/30 |
| Last modified on | 2020/05/05 10:58:54 |
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Basic information
Public title
Relationship of physical function, physical activity, and QOL in non-small-cell lung cancer patients
Acronym
Physical function and physical activity in NSCLC patients
Scientific Title
Relationship of physical function, physical activity, and QOL in non-small-cell lung cancer patients
Scientific Title:Acronym
Physical function and physical activity in NSCLC patients
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purposes of the study is to investigate muscle strength, exercise capacity, physical activity, nutrition, and QOL in NSCLC patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6 minute walk test, grip strength, knee extension strength, physical activity, balance function, QOL, nutrition, and QOL
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. NSCLC patients have received adjuvant therapy in Niigata Cancer Center Hospital
2. Patients aged 20 years or more.
Key exclusion criteria
1. Patients have not received evaluation physical function due to muscle skeletal disease or cerebrovascular disease
2. Patients have not received evaluation the questionnaire due to psycho social disease
3. Physician have inappropriate for participation in research
4. Patients who did not obtain informed consent to this study
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Morishita |
Organization
Niigata University of Health and Welfare
Division name
Department of physical therapy
Zip code
950-3198
Address
Shimami-cho 1398, Kita-ku, Niigata City
TEL
0252574300
morishita@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Morishita |
Organization
Niigata University of Health and Welfare
Division name
Department of physical therapy
Zip code
950-3198
Address
Shimami-cho 1398, Kita-ku, Niigata City
TEL
0252574300
Homepage URL
morishita@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Niigata University of Health and Welfare
Address
Niigata University of Health and Welfare
Tel
025-257-4455
kenshien@nuhw.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2017-65
Org. issuing International ID_1
Niigata Cancer Center Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Suspended
Date of protocol fixation
| 2017 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2017 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034002
