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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002303
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Satoko Miyawaki
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002767

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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