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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030373
Receipt No. 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

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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
Email 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
Email h16710mt@sfc.keio.ac.jp

Sponsor
Institute Keio University Graduate School of Health Management
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034676

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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