UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011229 |
|---|---|
| Receipt number | 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 18:01:59 |
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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
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
tonosakia@adm.ncn.ac.jp
Sponsor or person
Institute
Akiko Tonosaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013159
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| Registered date | File name |
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