UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Health Related Quality of Life via Computer-based Health Evaluation System (CHES) For Japanese Metastatic Breast Cancer Patients: A Pilot Study of Single Institution
Title of the study (Brief title)	CHES Pilot Study for Japanese Metastatic Breast Cancer Patients
Region	Japan

Condition
Condition	metastatic breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the compliance with health related quality of life monitoring in home through CHES regarding Japanese advanced or metastatic breast cancer patients who are treated with chemotherapy in outpatient unit.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Collection rate of questionnaire [The collected number of questionnaire / the planned number of questionnaire]
Key secondary outcomes	1)Time to deterioration 2)Rate of patients who show a minimally important difference score [Time to deterioration is defined as the time until clinically meaningful deterioration by a specified MID values is observed] [Literature-based threshold values for MID will be used for scales in the EORTC QLQ-C30]

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Written informed consent, with the understanding that the patient may withdraw consent at any time without prejudice 2) Patients with metastatic breast cancer. 3) Patients who are treated with chemotherapy and endocrine therapy. 4) Patients who have tablet phone or PC in home. 5) Patients with expected survival for more than 6 months.
Key exclusion criteria	Patients considered to be inappropriate for the study participation, as judged by the primary physician.
Target sample size	30

Research contact person
Name of lead principal investigator	Yuichiro Kikawa
Organization	Kobe City Medical Center General Hospital
Division name	Department of Breast Surgery
Address	2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo,Japan
TEL	0783024321
Email	u-1ro@kcho.jp

Public contact
Name of contact person	Yuichiro Kikawa
Organization	Kobe Medical Center General Hospital
Division name	Department of Breast Surgery
Address	2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo,Japan
TEL	0783024321
Homepage URL
Email	u-1ro@kcho.jp

Sponsor
Institute	Kobe Medical Center General Hospital
Institute
Department

Funding Source
Organization	Kobe Medical Center General Hospital
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 06 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
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	After enrollment, patients complete the first assessment with electric version of EORTC QLQ-C30 CHES in hospital. Then, patients complete the questionnaire at home by their own electric device once a week during the study period.

Management information
Registered date	2016 Year 07 Month 20 Day
Last modified on	2018 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026636