UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relation of the fatigue, the fatigue management barrier and the social support among breast cancer patients receiving endocrine therapy
Title of the study (Brief title)	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	Hiroko Komatsu
Organization	Keio University
Division name	Graduate School of Health Management
Address	35,shinanomachi,shinjuku-ku,Tokyo
TEL	03-5363-3733
Email	komah@sfc.keio.ac.jp

Public contact
Name of contact person	Miyu Takahashi
Organization	Keio University
Division name	Graduate School of Health Management Course for Nursing
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 11 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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