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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036002
Receipt No. R000040930
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)
Date of disclosure of the study information 2019/02/25
Last modified on 2019/02/25

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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
Middle name
Last name Akiko Tonosaki
Organization National Center for Global Health and Medicine
Division name National College of Nursing, Japan
Zip code
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
Middle name
Last name Akiko Tonosaki
Organization National Center for Global Health and Medicine
Division name National College of Nursing, Japan
Zip code
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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 02 Month 25 Day


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

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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