UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030373 |
|---|---|
| Receipt number | R000034676 |
| Scientific Title | The relation of the fatigue, the fatigue management barrier and the social support among breast cancer patients receiving endocrine therapy |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2018/06/13 15:51:02 |
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Basic information
Public title
The relation of the fatigue, the fatigue management barrier and the social support among breast cancer patients receiving endocrine therapy
Acronym
The relation of the fatigue, the fatigue management barrier and the social support among breast cancer patients receiving endocrine therapy
Scientific Title
The relation of the fatigue, the fatigue management barrier and the social support among breast cancer patients receiving endocrine therapy
Scientific Title:Acronym
The relation of the fatigue, the fatigue management barrier and the social support among breast cancer patients 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
The purpose of this study is to assess the relationship of the fatigue, the fatigue management barrier and the social support among breast cancer patients receiving endocrine therapy
Basic objectives2
Others
Basic objectives -Others
Relationship with fatigue management barriers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Fatigue
(Piper fatigue scale)
Key secondary outcomes
Degree of the fatigue management barriers
(Japanese version of the fatigue barriers scale)
Social support
(Japanese version of the social support scale )
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)Patient aged 20 years older
2)Patient who is informed of their diagnosis,stage and treatment by a physician
3)Outpatient who has received endocrine therapy less than five years three months later
4)Patient who a conversation with Japanese is possible,and can fill out a question paper
5)Patient who was able to participate in the study according to the primary physician's assessment, and agree with study
Key exclusion criteria
1)Patient who has recurrent breast cancer or metastasis
2)Patient a prognosis of less than 6 months
3)Patient who had cognitive and mental disorders
4)Patient who receives the diagnosis of the mental disease, or is treated for the mental disease
5)Performance status of 3 or more
6)Patient that participation is taken as impossibility by the primary physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Komatsu |
Organization
Keio University
Division name
Graduate School of Health Management
Zip code
Address
35,shinanomachi,shinjuku-ku,Tokyo
TEL
03-5363-3733
komah@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyu Takahashi |
Organization
Keio University
Division name
Graduate School of Health Management Course for Nursing
Zip code
Address
4411Endo,fujisawa-shi,Kanagawa
TEL
0466-49-6265
Homepage URL
h16710mt@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University Graduate School of Health Management
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Address
Tel
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)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design:Obsevational cross-sectional study
Item to examine
1)fatigue
2)fatigue management barrier
3)social support
Management information
Registered date
| 2017 | Year | 12 | Month | 13 | Day |
Last modified on
| 2018 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034676
