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

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 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


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

Value
https://center6.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