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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | breast cancer | ||
Classification by specialty |
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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
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 140 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
komah@sfc.keio.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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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 |
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Last modified on |
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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 |