UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002303 |
|---|---|
| Receipt number | R000002767 |
| Scientific Title | Development of walking exercise program for fatigue management of breast cancer patient |
| Date of disclosure of the study information | 2014/02/26 |
| Last modified on | 2009/08/06 15:34:47 |
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Basic information
Public title
Development of walking exercise program for fatigue management of breast cancer patient
Acronym
Development of walking exercise program for fatigue management of breast cancer patient
Scientific Title
Development of walking exercise program for fatigue management of breast cancer patient
Scientific Title:Acronym
Development of walking exercise program for fatigue management of breast cancer patient
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to development of the walking exercise program for fatigue management which is based on The Integrated Approach to Symptom Management of Breast Cancer Patient receiving adjuvant chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF-36
Cancer Fatigue Scale
NRS
revel of selfcare
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
exercise
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
Female
Key inclusion criteria
over 20 years old
Breast Cancer
recieving adjuvant chemotherapy
Key exclusion criteria
contraindication exercise
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoko Miyawaki |
Organization
Kochi Women University
Division name
master
Zip code
Address
Kochi-shi Ike
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kochi Women University
Division name
master
Zip code
Address
TEL
090-4894-7649
Homepage URL
Sponsor or person
Institute
Satoko Miyawaki
Institute
Department
Personal name
Funding Source
Organization
Non proit foundation YUMI ZAIDAN
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 06 | Day |
Last modified on
| 2009 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002767
