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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032177
Receipt No. 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 2019/04/11

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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
Email 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
Email gmd20076@s.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email 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
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
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
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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
2019 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036668

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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