UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the employment of breast cancer patients undergoing medical treatment
Title of the study (Brief title)	A study on the employment of breast cancer patients undergoing medical treatment
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the working status of breast cancer patients after surgery.
Basic objectives2	Others
Basic objectives -Others	To examine what affects the state of employment.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Extracted categories through cording
Key secondary outcomes

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	65 years-old >
Gender	Female
Key inclusion criteria	1) Patients 20 years old or more and under 65 (at the time of breast cancer operation), 2) Patients with work (at the time of breast cancer operation), 3) Patients with a performance Status(PS) of 0-1
Key exclusion criteria	Patients considered inappropriate for the study by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Ryoko Taguchi
Organization	Juntendo University of Medicine
Division name	Department of Breast Surgery and Oncology
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421
TEL	03-3813-3111
Email	r-taguchi@juntendo.ac.jp

Public contact
Name of contact person	Ryoko Taguchi
Organization	Juntendo University of Medicine
Division name	Department of Breast Surgery and Oncology
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421
TEL	03-3813-3111
Homepage URL
Email	r-taguchi@juntendo.ac.jp

Sponsor
Institute	Department of Breast Surgery and Oncology, Juntendo University of Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	順天堂大学医学部附属順天堂医院（東京）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 25 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We perform qualitative research on breast cancer patients with employment after surgery.

Management information
Registered date	2016 Year 04 Month 05 Day
Last modified on	2018 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025126