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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036742
Receipt No. R000041865
Scientific Title Work sustainability and symptoms of breast cancer survivors receiving endocrine therapy
Date of disclosure of the study information 2019/05/15
Last modified on 2019/05/15

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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
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)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
Registered date File name

Research case data
Registered date File name


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