![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000042955 |
Receipt No. | 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 |
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 |
|
Condition | |||
Condition | Breast cancer | ||
Classification by specialty |
|
||
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
Institute | Sagara Hospital |
Institute | |
Department |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049007 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |