UMIN-ICDR Clinical Trial

Unique ID issued by UMIN UMIN000027720
Receipt number R000028333
Scientific Title Clinical Survey of Fatigue in Breast Cancer Survivors
Date of disclosure of the study information 2017/08/15
Last modified on 2019/06/18 22:42:32

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Basic information

Public title

Clinical Survey of Fatigue in Breast Cancer Survivors

Acronym

Clinical Survey of Fatigue in Breast Cancer Survivors

Scientific Title

Clinical Survey of Fatigue in Breast Cancer Survivors

Scientific Title:Acronym

Clinical Survey of Fatigue in Breast Cancer Survivors

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery Nursing

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the prevalence and related factor of fatigue in breast cancer survivors.

Basic objectives2

Others

Basic objectives -Others

To investigate the status of breast cancer survivors with fatigue

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cancer Fatigue Scale (CFS)

Key secondary outcomes

NRS
Hospital Anxiety and Depression Scale(HADS)
Mindful Attention Awareness Scale(MAAS)
Personal background


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) Patients diagnosed with breast cancer
2) Patients aged twenty or over
3) Outpatients who had breast cancer surgery
4) Individuals who sign the consent document after explanation of this study

Key exclusion criteria

1) Patients with cognitive dysfunction or mental disorders
2) Patients who are considered to be ineligible for the study participation based on the doctor's judgment

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuko Nin

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Human Health Science

Zip code


Address

53 Shogoin Kawaharacho, Sakyoku, Kyoto

TEL

075-751-3946

Email

nin@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaori Ikeuchi

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Human Health Science

Zip code


Address

53 Shogoin Kawaharacho, Sakyoku, Kyoto

TEL

075-751-3946

Homepage URL


Email

ikeuchi.kaori.74m@st.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto University

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2017 Year 08 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

Completed

Date of protocol fixation

2017 Year 06 Month 09 Day

Date of IRB

2017 Year 06 Month 12 Day

Anticipated trial start date

2017 Year 07 Month 27 Day

Last follow-up date

2017 Year 12 Month 30 Day

Date of closure to data entry

2017 Year 12 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

questionary investigation


Management information

Registered date

2017 Year 06 Month 12 Day

Last modified on

2019 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name