UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032177 |
|---|---|
| Receipt number | R000036668 |
| Scientific Title | Satisfaction and quality of life after immediate breast reconstruction in Japan. A multi-center cohort study |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2024/10/22 12:36:28 |
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Basic information
Public title
Satisfaction and quality of life after immediate breast reconstruction in Japan. A multi-center cohort study
Acronym
SAQLA study
Scientific Title
Satisfaction and quality of life after immediate breast reconstruction in Japan. A multi-center cohort study
Scientific Title:Acronym
SAQLA study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this multicenter longitudinal observational study is to investigate the HRQOL and satisfaction of breast cancer survivors after mastectomy and immediate breast reconstruction at 7 leading institutions in Japan.
Basic objectives2
Others
Basic objectives -Others
Satisfaction, HRQOL
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The time-dependent change of satisfaction with breasts score of BREAST-Q during postoperative 12 months
Key secondary outcomes
The time-dependent change of satisfaction with breasts score of BREAST-Q during postoperative 36 months.
BREAST-Q subscales other than satisfaction with breasts (satisfaction with implants, adverse effect of radiation, psychosocial well-being, sexual well-being, chest well-being, abdominal well-being, satisfaction of the abdomen, satisfaction with back appearance and satisfaction with functions of back and shoulders)
SF-8 summary score (Physical and mental component summary)
Evaluation of the burden by breast reconstruction surgery.
Complication rates
Evaluation of bilateral symmetry
( Harris 4 step evaluation, MammaBalance score)
Recurrence rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Pathologically diagnosed as breast cancer.
2)Total masterectomy including Bt,SSM,NSM.
3) Breast surgeon decided the indication for breast reconstruction and immediate breast reconstruction is planned.
4)Age 20 years or more, and 75 years or less
5) ECOG Performance Status 0 or 1
6) The written informed consent has been obtained from the patients for participating in the research.
Key exclusion criteria
1) Reconstruction for partial mastectomy
2) Cases in which total mastectomy / reconstruction was performed after partial mastectomy.
3)Cases in which ipsilateral breast reconstruction was performed before (re-reconstruction)
4) Heterochronic and simultaneous bilateral breast cancer
5) Cases in which breast appearance has remarkably changed by previous surgery such as augmentation mammoplasty before.
6) Difficult participate in the study due to complications of dementia or psychiatric symptoms
7) Cases judged by doctor to be unsuitable for study
8) Patients who do not own devices
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kimata |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Plastic and Reconstructive Surgery
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-Ku, Okayama
TEL
086-275-7214
ykimata@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Saiga |
Organization
Okayama university hospital
Division name
Plastic surgery
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-Ku, Okayama
TEL
086-275-7214
Homepage URL
gmd20076@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iwate Medical University Hospital
The Cancer Institute Hospital of JFCR
Showa University Hospital
University of Tsukuba Hospital
Osaka University Hospital
Yokohama City University Medical Center
National Center for Child Health and Development
Tokyo University of Pharmacy and Life Sciences
Graduate School of Medicine, The University of Tokyo
Tohoku University Hospital
National Cancer Center Hospital East
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-Ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
岡山大学病院（岡山県）、岩手医科大学附属病院（岩手県）、癌研有明病院（東京都）、昭和大学病院（東京都）、筑波大学附属病院（茨城県）、大阪大学医学部附属病院（大阪府）、横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 10 | 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
412
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
| 2017 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
We investigate the time-dependent changes in level of satisfaction and HRQOL based on BREAST-Q and will perform exploratory comparison between the reconstructive procedures. We also investigate the factors which affect on these outcomes such as social background, physical findings, breast cancer surgery procedure, adjuvant therapy.
Management information
Registered date
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036668
