UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013300 |
|---|---|
| Receipt number | 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 13:38:53 |
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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
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
a-sato@sapmed.ac.jp
Sponsor or person
Institute
KKR Sapporo Medical Center TONAN Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015513
