UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042955 |
|---|---|
| Receipt number | R000049007 |
| Scientific Title | Prospective observational study investigating clinical impact by using electronic patient-reported outcomes (ePRO) on the management of adverse events of chemotherapy |
| Date of disclosure of the study information | 2021/01/12 |
| Last modified on | 2021/01/09 15:20:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective observational study investigating clinical impact by using electronic patient-reported outcomes (ePRO) on the management of adverse events of chemotherapy
Acronym
Management of adverse events by using ePRO
Scientific Title
Prospective observational study investigating clinical impact by using electronic patient-reported outcomes (ePRO) on the management of adverse events of chemotherapy
Scientific Title:Acronym
Management of adverse events by using ePRO
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical benefits by using ePRO in the management of adverse events during pharmacotherapy for breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of unscheduled visits
Key secondary outcomes
Compliance with inputting adverse events into the ePRO system
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
Male and Female
Key inclusion criteria
(1) Pathologically diagnosed as breast cancer
(2) Receiving systemic anticancer pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) for breast cancer
(3) Capable of using electronic devices
(4) Written consent for the study personally obtained from the subject
Key exclusion criteria
(1) Difficulty in using electronic devices
(2) Receiving hormone therapy only
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | Taira |
Organization
Sagara Hospital
Division name
Department of Oncology
Zip code
892-0833
Address
3-31 Matsubara-cho, Kagoshima City
TEL
099-224-1800
ttaira-tt@sagara.or.jp
Public contact
Name of contact person
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | Taira |
Organization
Sagara Hospital
Division name
Department of Oncology
Zip code
892-0833
Address
3-31 Matsubara-cho, Kagoshima City
TEL
099-224-1800
Homepage URL
ttaira-tt@sagara.or.jp
Sponsor or person
Institute
Sagara Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HAKUAIKAI Social Medical Corporation
Address
3-31 Matsubara-cho, Kagoshima City
Tel
099-224-1800
ttaira-tt@sagara.or.jp
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
| 2021 | Year | 01 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the clinical effects of using ePRO for side effect management of breast cancer pharmacotherapy, and then introduce ePRO into clinical practice.
Management information
Registered date
| 2021 | Year | 01 | Month | 09 | Day |
Last modified on
| 2021 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049007
