UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023034 |
|---|---|
| Receipt number | R000026549 |
| Scientific Title | A prospective observational study of physical activity in patients undergoing surgery for thoracic malignancy. |
| Date of disclosure of the study information | 2016/07/10 |
| Last modified on | 2023/01/10 10:03:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective observational study of physical activity in patients undergoing surgery for thoracic malignancy.
Acronym
A prospective observational study of physical activity in patients undergoing surgery for thoracic malignancy.
Scientific Title
A prospective observational study of physical activity in patients undergoing surgery for thoracic malignancy.
Scientific Title:Acronym
A prospective observational study of physical activity in patients undergoing surgery for thoracic malignancy.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the process of recovering in patients undergoing thoracic surgery by measuring physical activity.
Basic objectives2
Others
Basic objectives -Others
To analyze relationship among QOL, life style, and symptoms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery rate of physical activity in 12 months after surgery
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. having ECOG-PS 0-2
2. patients who are planed to receive thoracic surgery
3. having operable lung cancer in stage I, II, or III
4. obtaining written informed consent
Key exclusion criteria
Patients having risk factors for physical assessment including respiratory, cardiological, orthopedic, and neurological complications.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ayumu |
| Middle name | |
| Last name | Morikawa |
Organization
Shizuoka Cancer Center
Division name
Nursing division
Zip code
411-8777
Address
1007 Shimonagakubo, Sunto-gun, Nagaizumi-cho
TEL
055-989-5222
a.morikawa@scchr.jp
Public contact
Name of contact person
| 1st name | Ayumu |
| Middle name | |
| Last name | Morikawa |
Organization
Shizuoka Cancer Center
Division name
Nursing Division
Zip code
411-8777
Address
1007 Shimonagakubo, Sunto-gun, Nagaizumi-cho
TEL
055-989-5222
Homepage URL
a.morikawa@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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Sunto-gun, Nagaizumi-cho
Tel
055-989-5222
info@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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 10 | 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
20
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026549
