UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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

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