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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023250
Receipt No. R000026636
Scientific Title 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
Date of disclosure of the study information 2016/09/01
Last modified on 2018/02/18

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Basic information
Public title 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
Acronym CHES Pilot Study for Japanese Metastatic Breast Cancer Patients
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichiro Kikawa
Organization Kobe City Medical Center General Hospital
Division name Department of Breast Surgery
Zip code
Address 2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo,Japan
TEL 0783024321
Email u-1ro@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Kikawa
Organization Kobe Medical Center General Hospital
Division name Department of Breast Surgery
Zip code
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)

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
2016 Year 09 Month 01 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
2016 Year 05 Month 06 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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