UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013647 |
|---|---|
| Receipt number | R000015929 |
| Scientific Title | the Setouchi Breast Cancer Cohort Study |
| Date of disclosure of the study information | 2014/04/07 |
| Last modified on | 2018/04/09 07:51:01 |
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Basic information
Public title
the Setouchi Breast Cancer Cohort Study
Acronym
SBCCS
Scientific Title
the Setouchi Breast Cancer Cohort Study
Scientific Title:Acronym
SBCCS
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The primary purpose of the Setouchi Breast Cancer Cohort Study (SBCCS) is to investigate the effect on breast cancer outcomes of modifiable lifestyle factors after breast cancer diagnosis. A further purpose is to evaluate the status of breast cancer survivors, including physical, functional, social, and psychological well-being, and the needs of survivors after diagnosis, based on a comprehensive and longitudinal investigation.
Basic objectives2
Others
Basic objectives -Others
The primary purpose of the Setouchi Breast Cancer Cohort Study (SBCCS) is to investigate the effect on breast cancer outcomes of modifiable lifestyle factors, including physical activity, smoking, alcohol consumption, obesity and weight gain after diagnosis, alternative medicine, and dietary factors, after breast cancer diagnosis. A further purpose is to evaluate the status of breast cancer survivors, including physical, functional, social, and psychological well-being, and the needs of survivors after diagnosis, based on a comprehensive and longitudinal investigation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
disease-free survival (DFS), defined as the time from enrollment to the earliest documentation of disease relapse, asynchronous breast cancer, any secondary cancer, or death due to any cause.
Key secondary outcomes
Secondary endpoints include overall survival (OS), health-related quality of life (HRQoL), breast cancer-related symptoms, and adverse events.
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
| Not applicable |
Gender
Female
Key inclusion criteria
(i)Histological or cytological diagnosis of breast cancer and planned radical treatment for the disease at a participating institution.
(ii)Women aged 20 years old or above.
(iii)Signed written informed consent.
Key exclusion criteria
Exclusion Criteria
(i)Breast cancer with distant metastasis (Stage IV).
(ii)Ineligibility for the study based on the decision of an investigator.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naruto Taira |
Organization
Okayama university hoispital
Division name
Department of Breast and endocrine surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
+81-86-235-7265
ntaira@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Doumae, Fujiwara |
Organization
the Non-Profit Organization Setouchi Breast Project Comprehensive Support (SBP-CS)
Division name
Office
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
+81-86-235-7265
Homepage URL
http://setouchi-bp.com/
office@setouchi-bp.com
Sponsor or person
Institute
the Non-Profit Organization Setouchi Breast Project Comprehensive Support (SBP-CS)
Institute
Department
Personal name
Funding Source
Organization
the Non-Profit Organization Setouchi Breast Project Comprehensive Support (SBP-CS
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Cancer Center, Research Center for Cancer Prevention and Screening
Name of secondary funder(s)
Health and Labour Sciences Research Grant (Clinical Cancer Research,H22-035, H25-A-16); Grant-in-Aid for Scientific Research (C,24591906) ; Research Support from AstraZeneca K.K. (United States).
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
香川県立中央病院（香川県）
四国がんセンター（愛媛県）
岡山赤十字病院（岡山県）
福山医療センター（広島県）
水島協同病院（岡山県）
愛媛県立中央病院（愛媛県）
高知医療センター（高知県）
岡山労災病院（岡山県）
福山市民病院（広島県）
岡山医療センター（岡山県）
広島市立広島市民病院 （ 広島県）
松江赤十字病院（島根県）
姫路聖マリア病院（兵庫県）
高知大学病院（高知県）
川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 20 | Day |
Other
Other related information
Lifestyle
Lifestyle at the time of and after breast cancer diagnosis will be assessed using a self-reported questionnaire developed in the Japan Public Health Center-based Prospective Study (JPHC study).
Psychosocial factors
Psychosocial factors will be assessed using the Public Health Research Foundation - Stress Check List (PHRF-SCL), Stress-Coping Assessment Questionnaire, Health Hope Index (HHI), Perceived Positive Change, and Hospital Anxiety and Depression Scale (HADS).
Social background and reproductive factors
Marital status, children, presence of partner, household income, educational background, and work status will be assessed using original items. Menstrual status at the time of and after breast cancer diagnosis, and reproductive and breastfeeding history will also be assessed using original items.
Health related quality of life (HRQoL) and patient-reported symptoms
HRQoL will be assessed using established questionnaires: the Functional Assessment of Cancer Therapy (FACT) -Endocrine Symptoms (ES), -Breast (B), and -Taxane; and the MOS 36-Item Short-Form Health Survey (SF36®). Cancer-related fatigue will be assessed using the Cancer Fatigue Scale (CFS). Chemotherapy-induced peripheral neurotoxicity will be assessed using the Patient Neurotoxicity Questionnaire (PNQ). Breast cancer-related symptoms will be assessed using 25 items on an original self-reported symptoms checklist developed for this study.
Other factors
The status of use of alternative medicine after breast cancer diagnosis and the informational and supportive needs of patients at each time point will be assessed using original items.
Evaluation points
The evaluation time points for each questionnaire are at registration (baseline) and at 1, 2, 3 and 5 years after registration.
Management information
Registered date
| 2014 | Year | 04 | Month | 05 | Day |
Last modified on
| 2018 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015929
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