UMIN-CTR Clinical Trial

Basic information
Public title	A preliminary research for the smart mobile system of monitoring adverse events in patients receiving lung cancer chemotherapy at outpatient setting (development number 02)
Acronym	Development of mobile monitoring system 02
Scientific Title	A preliminary research for the smart mobile system of monitoring adverse events in patients receiving lung cancer chemotherapy at outpatient setting (development number 02)
Scientific Title:Acronym	Development of mobile monitoring system 02
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Test run of the system (development No.02), and evaluation on convenience and tolerability of the system
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	The rate of self care adherence which are calculated by counts of data submission days.
Key secondary outcomes	Correlation between selfcare adherence rate and depression rating scale at the start day - Coincidence of the evaluations of adverse events between by a patient and by the attending doctors.

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	A person - with pathologically diagnosed lung cancer - who receives chemotherapy with the regimen of intravenous administration of more than one anti-cancer drugs - who receive chemotherapy twice or more - who can use a tablet to submit the self-evaluation of monitoring physical signs - who is more than 20 years old - whose ECOG Performance status (PS) ranges from 0 to 2 - who has no severe dysfunctions of major organs; bone marrow, heart, liver and kidney
Key exclusion criteria	A person - who has no confirmed diagnosis - who cannot receive the standard treatment of cancer due to complications - who will receive less than 80% of prescribed dose with respect to all anti-cancer drugs in regimen - who receives chemoradiotherapy; radiation therapy and simultaneous chemotherapy
Target sample size	40

Research contact person
Name of lead principal investigator	1st name AKIKO Middle name Last name TONOSAKI
Organization	National Center for Global Health and Medicine
Division name	National College of Nursing, Japan
Zip code	204-8575
Address	1cho-me 2, Umezono, Kiyose-shi, Tokyo, Japan
TEL	042-495-2211
Email	tonosakia@adm.ncn.ac.jp

Public contact
Name of contact person	1st name AKIKO Middle name Last name TONOSAKI
Organization	National Center for Global Health and Medicine
Division name	National College of Nursing, Japan
Zip code	204-8575
Address	1cho-me 2, Umezono, Kiyose-shi, Tokyo, Japan
TEL	042-495-2211
Homepage URL
Email	tonosakia@adm.ncn.ac.jp

Sponsor
Institute	National Center for Global Health and Medicine National College of Nursing, Japan
Institute
Department

Funding Source
Organization	JSPS KAKENHI
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo University of Science Faculty of Science and Technology Department of Information Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Global Health and Medicine
Address	1-2-1 Toyama, Shinjyuku-ku, Tokyo, Japan
Tel	03-3202-7181
Email	rinrijm@hosp.ncgm.go.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	研究開発法人　国立国際医療研究センター病院（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 25 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	15
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Currently　under analysis. It takes time because we are busy dealing with the spread of Covid-19 infection.
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	2018 Year 12 Month 20 Day
Date of IRB	2018 Year 12 Month 11 Day
Anticipated trial start date	2019 Year 01 Month 29 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2019 Year 07 Month 31 Day
Date analysis concluded	2020 Year 07 Month 31 Day

Other

Other related information

Study design is preliminary observation based on convenience sampling. Subjects are who receive the chemotherapy for lung cancer at the respiratory medicine of the specific medical institution during the research period, and whose cases meet the selection criteria of our study. List of data items are first patients' background information, secondly those are age at treatment, disease type, stage of disease, chemotherapy regimen, administration date of anticancer drug and comorbidities, treatment and adverse events information, those are evaluation on adverse event according to CTCAE v4.0 JCOG, results of blood and biochemical test, vital signs, depression rating scale, self-assessment of physical condition.

Management information
Registered date	2019 Year 02 Month 25 Day
Last modified on	2021 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040930