UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004943 |
|---|---|
| Receipt number | R000005884 |
| Scientific Title | Observational study on the associations between physical function and health-related quality of life in gastrointestinal cancer patients. |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2015/08/25 19:43:19 |
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Basic information
Public title
Observational study on the associations between physical function and health-related quality of life in gastrointestinal cancer patients.
Acronym
Observational study on the associations between physical function and health-related quality of life in gastrointestinal cancer patients.
Scientific Title
Observational study on the associations between physical function and health-related quality of life in gastrointestinal cancer patients.
Scientific Title:Acronym
Observational study on the associations between physical function and health-related quality of life in gastrointestinal cancer patients.
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conduct to evaluate the associations between perioperative changes of physical function and health-related quality of life in gastrointestinal cancer patients.
Basic objectives2
Others
Basic objectives -Others
To investigate Patient-Reported Outcomes
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Health-related quality of life
Physical function
Key secondary outcomes
Body composition
Psychological function
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Gastrointestinal cancer patients aged 20 or over undergoing surgery
2. Patients who can fill out the questionnaires adequately after granting informed consent
Key exclusion criteria
1. Patients under 20 years old
2. Patients with metastatic cancer
3. Patients with contraindications for exercise caused by cardiac illness, immune abnormality, and thrombopenia
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Miura |
Organization
Kobe University Hospital
Division name
Department of Rehabilitation
Zip code
Address
7-5-2 Kusunoki Chuo Kobe 650-0017 JAPAN
TEL
078-382-5111
miura@kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Makiura |
Organization
Kobe University Graduate School
Division name
Faculty of Health Sciences
Zip code
Address
7-10-2 Tomogaoka Suma Kobe 654-0142 JAPAN
TEL
078-792-2555
Homepage URL
d.makiura@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Purpose: To investigate the associations between physical function and health-related quality of life in gastrointestinal cancer patients.
Design: Prospective observational study
Management information
Registered date
| 2011 | Year | 01 | Month | 25 | Day |
Last modified on
| 2015 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005884
