UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023250 |
|---|---|
| Receipt number | 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 14:33:07 |
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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
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
u-1ro@kcho.jp
Sponsor or person
Institute
Kobe Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
