UMIN-CTR Clinical Trial

Basic information
Public title	Work sustainability and symptoms of breast cancer survivors receiving endocrine therapy
Acronym	Work sustainability and symptoms of breast cancer survivors receiving endocrine therapy
Scientific Title	Work sustainability and symptoms of breast cancer survivors receiving endocrine therapy
Scientific Title:Acronym	Work sustainability and symptoms of breast cancer survivors receiving endocrine therapy
Region	Japan

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

Objectives
Narrative objectives1	This study tests the following hypotheses with breast cancer survivors receiving adjuvant endocrine therapy. 1) Survivors who report stably employed have a less symptom burden than their counterparts. 2) Survivors who report stably employed receive a more work support than their counterparts. 3) Working survivors who report greater overall work impairment have a higher symptom burden than their counterparts.
Basic objectives2	Others
Basic objectives -Others	The relationships between work sustainability, work productivity and activity impairment (overall work impairment) and symptoms, work support
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Work sustainability(work status at the time of diagnosis and present)
Key secondary outcomes	Work productivity and activity impairment (overall work impairment) Symptoms Work support

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
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	1)diagnosed with breast cancer 2)aged from 20 to 64 3)receiving endocrine therapy for more than 3 months and less than 5 years following surgery, chemotherapy, targeted therapy, radiation therapy as necessary 4)able to communicate in Japanese and complete a questionnaire 5)who understands the purpose of this study and agrees to participate
Key exclusion criteria	1)with metastasis or recurrence 2)with a history of cognitive/ mental disorder prior to the diagnosis of cancer 3)no longer working because of other health problems
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Hiroko Middle name Last name Komatsu
Organization	Keio University Graduate School of Health Management
Division name	Nursing
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3733
Email	komah@sfc.keio.ac.jp

Public contact
Name of contact person	1st name Mayumi Middle name Last name Nakao
Organization	Keio University Graduate School of Health Management
Division name	Nursing
Zip code	252-0883
Address	4411 Endo, Fujisawa-shi, Kanagawa
TEL	0466-49-6265
Homepage URL
Email	mayumina@sfc.keio.ac.jp

Sponsor
Institute	Keio University Graduate School of Health Management
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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	慶應義塾大学病院(東京都）　　Keio University Hospital(Tokyo)

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 15 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 25 Day
Date of IRB	2019 Year 04 Month 25 Day
Anticipated trial start date	2019 Year 05 Month 15 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Design: Observational cross-sectional study This study tests whether symptom burden and work support are associated with work sustainability and work productivity and activity impairment.

Management information
Registered date	2019 Year 05 Month 14 Day
Last modified on	2019 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041865

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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