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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011229
Receipt No. R000013159
Scientific Title Development of a program aiming to recover fitness of breast cancer survivors who receiving chemotherapy
Date of disclosure of the study information 2013/07/19
Last modified on 2015/03/04

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Basic information
Public title Development of a program aiming to recover fitness of breast cancer survivors who receiving chemotherapy
Acronym RFitBC
Scientific Title Development of a program aiming to recover fitness of breast cancer survivors who receiving chemotherapy
Scientific Title:Acronym RFitBC
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Development and eveluation of facilitated nursing program for daily physical activity with patients receiving breast cancer chemotherapy
Basic objectives2 Others
Basic objectives -Others Evaluating effects with physical acrtivity for an adequate body components and improving their depression
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes daily acitivity intensity
Key secondary outcomes body component
depression

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Education and counseling for daily physical activity
Interventions/Control_2 without education and counseling for daily physical activity
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
72 years-old >=
Gender Female
Key inclusion criteria primary breast cancer
stage 1 to 3A
Chemotherapy
Key exclusion criteria pacemaker inserted
functional impairment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Tonosaki
Organization National College of Nursing Japan
Division name oncology nursing
Zip code
Address Umezono Kiyose Tokyo
TEL 81-42-495-2211
Email tonosakia@adm.ncn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Tonosaki
Organization National College of Nursing Japan
Division name oncology nursing
Zip code
Address Umezono Kiyose Tokyo
TEL 042-495-2406
Homepage URL
Email tonosakia@adm.ncn.ac.jp

Sponsor
Institute Akiko Tonosaki
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research (B)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Showa University Hospital
National Cancer Center Hospital East
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 1301
Org. issuing International ID_1 Showa University Hospital
Study ID_2
Org. issuing International ID_2 National Cancer Center Hospital East
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 19 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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 15 Day
Last follow-up date
2014 Year 02 Month 28 Day
Date of closure to data entry
2014 Year 02 Month 28 Day
Date trial data considered complete
2014 Year 07 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 19 Day
Last modified on
2015 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013159

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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