UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036858 |
|---|---|
| Receipt number | R000041993 |
| Scientific Title | Monitoring research on symptoms and quality of life using electronic patient-reported outcome (ePRO) in patients undergoing chemotherapy for metastatic breast cancer |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/05/27 09:37:35 |
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Basic information
Public title
Monitoring research on symptoms and quality of life using electronic patient-reported outcome (ePRO) in patients undergoing chemotherapy for metastatic breast cancer
Acronym
ePRO monitoring research on metastatic breast cancer
Scientific Title
Monitoring research on symptoms and quality of life using electronic patient-reported outcome (ePRO) in patients undergoing chemotherapy for metastatic breast cancer
Scientific Title:Acronym
ePRO monitoring research on metastatic breast cancer
Region
| Japan |
Condition
Condition
metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To monitor ePRO-treated symptoms and quality of life for breast cancer patients undergoing chemotherapy and evaluate their relevance and reliability
Basic objectives2
Others
Basic objectives -Others
Analyze the relationship between ePRO monitoring data and health related outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
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) Those who have been diagnosed as "histologically primary breast cancer"
2) Patients who are diagnosed with metastatic breast cancer and difficult to cure
3) Those who are or are planning to take chemotherapy for metastatic breast cancer
4) Persons who obtained written consent for participation in research
Key exclusion criteria
1)Those who have difficulty in answering ePRO
2) A person in charge of research who has judged that incorporation into research is inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naruto |
| Middle name | |
| Last name | Taira |
Organization
Okayama university hospital
Division name
breast and endocrine surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
0862357265
ntaira@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Naruto |
| Middle name | |
| Last name | Taira |
Organization
Okayama university hospital
Division name
breast and endocrine surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
0862357265
Homepage URL
ntaira@md.okayama-u.ac.jp
Sponsor or person
Institute
NPO comprehensive support for setouchi breast project
Institute
Department
Personal name
Funding Source
Organization
National institute for public health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
N
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6503
okayama@esct.bvits.com
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
| 2019 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will monitor symptoms and quality of life for breast cancer patients undergoing chemotherapy using ePRO, evaluate their relevance and reliability, and
Implement for the purpose of obtaining basic information for clinical application.
Management information
Registered date
| 2019 | Year | 05 | Month | 27 | Day |
Last modified on
| 2019 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041993
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
