UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021782
Receipt number R000025119
Scientific Title A retrospective study on sick leave at workplace taken by breast cancer patients
Date of disclosure of the study information 2016/04/06
Last modified on 2017/03/31 16:47:32

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Basic information

Public title

A retrospective study on sick leave at workplace taken by breast cancer patients

Acronym

A retrospective study on sick leave at workplace taken by breast cancer patients

Scientific Title

A retrospective study on sick leave at workplace taken by breast cancer patients

Scientific Title:Acronym

A retrospective study on sick leave at workplace taken by breast cancer patients

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine 1) sick leave at workplace taken by breast cancer patients who underwent operation and treatment, 2) the correlation between 1) and medial factors, and 3) the cooperation between surgeons and occupational physicians on sick leave and return to work.

Basic objectives2

Others

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sick leave taken by breast cancer patients

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

Patients 20 years old or more and under 65 (at the time of breast cancer operation)

Key exclusion criteria

Patients considered inappropriate for the study by the investigator

Target sample size

1300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukako Okude

Organization

Juntendo University Hospital

Division name

Nursing counseling room

Zip code


Address

3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421

TEL

03-3813-3111

Email

yokude@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryoko Taguchi(Acting Ms.Yukako Okude)

Organization

Juntendo University of Medicine

Division name

Department of Breast Surgery and Oncology

Zip code


Address

2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421

TEL

03-3813-3111

Homepage URL


Email

r-taguchi@juntendo.ac.jp


Sponsor or person

Institute

Department of Breast Surgery and Oncology, Juntendo University of Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2015 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 04 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We examine the data of medical certificates issued in the hospital for breast cancer patients.


Management information

Registered date

2016 Year 04 Month 05 Day

Last modified on

2017 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025119


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name