UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036002 |
|---|---|
| Receipt number | 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 | 2021/03/01 14:03:48 |
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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 | 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
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
tonosakia@adm.ncn.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
National College of Nursing, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040930
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
