UMIN-CTR Clinical Trial

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
Institute	Kyoto University Graduate School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028333