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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013300
Receipt No. R000015513
Scientific Title Study of comprehensive rehabilitation in breast cancer patients treated with partial mastectomy and sentinel node biopsy
Date of disclosure of the study information 2014/02/28
Last modified on 2014/02/28

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Basic information
Public title Study of comprehensive rehabilitation in breast cancer patients treated with partial mastectomy and sentinel node biopsy
Acronym Study of comprehensive rehabilitation in breast cancer patients treated with partial mastectomy and sentinel node biopsy
Scientific Title Study of comprehensive rehabilitation in breast cancer patients treated with partial mastectomy and sentinel node biopsy
Scientific Title:Acronym Study of comprehensive rehabilitation in breast cancer patients treated with partial mastectomy and sentinel node biopsy
Region
Japan

Condition
Condition Breast cancer patients treated with partial mastectomy and sentinel node biopsy
Classification by specialty
Breast surgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Usefulness of comprehensive cancer rehabilitation with a focus on improving the incidence of shoulder joint disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Problems of shoulder joint range of motion(ROM Scale)
Key secondary outcomes Lymphedema, QOL score, Questionnaire survey

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver Other
Interventions/Control_1 Comprehensive Cancer rehabilitation enforcement
Interventions/Control_2 Guidance by brochure
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
80 years-old >
Gender Female
Key inclusion criteria After receiving a full explanation upon participation in this study, patients with documented consent was obtained
Key exclusion criteria Patients principal investigator was deemed inappropriate as a subject
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MASAYA KAWADA
Organization KKR Sapporo Medical Center TONAN Hospital
Division name Breast Surgery
Zip code
Address Hokkaido, Sapporo, Chuo-ku, N1, W6
TEL 011-231-2121
Email kawada@tonan.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name AKINORI SATO
Organization KKR Sapporo Medical Center TONAN Hospital
Division name Department of rehabilitation
Zip code
Address Hokkaido, Sapporo, Chuo-ku, N1, W6
TEL 011-231-2121
Homepage URL
Email a-sato@sapmed.ac.jp

Sponsor
Institute KKR Sapporo Medical Center TONAN Hospital
Institute
Department

Funding Source
Organization KKR Sapporo Medical Center TONAN Hospital
Organization
Division
Category of Funding Organization Other
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 KKR札幌医療センター斗南病院(北海道)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 28 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 Enrolling by invitation
Date of protocol fixation
2013 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 02 Month 28 Day
Date trial data considered complete
2016 Year 06 Month 30 Day
Date analysis concluded
2016 Year 10 Month 29 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 28 Day
Last modified on
2014 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015513

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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