UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036742 |
|---|---|
| Receipt number | 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 | 2022/03/28 11:04:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mayumina@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University Graduate School of Health Management
Institute
Department
Personal name
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
| 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
Main results already published
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
| 2022 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.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 |
