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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040654
Receipt No. R000046397
Scientific Title Telehome Monitoring-based Telenursing for Older Adults with Lung Cancer: Focus on Characteristics of Symptoms and How to Manage This Condition during Home Care
Date of disclosure of the study information 2020/06/04
Last modified on 2020/12/05

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Basic information
Public title Practice of Telehome Monitoring-based Telenursing for Older Adults with Lung Cancer: Focus on Characteristics of Symptoms and How to Manage This Condition during Home Care
Acronym Practice of Telehome Monitoring-based Telenursing for Older Adults with Lung Cancer
Scientific Title Telehome Monitoring-based Telenursing for Older Adults with Lung Cancer: Focus on Characteristics of Symptoms and How to Manage This Condition during Home Care
Scientific Title:Acronym Telehome Monitoring-based Telenursing for Older Adults with Lung Cancer
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Understanding for characteristics of symptoms due to trigger points and experience during telehome monitoring-based telenursing for older adults with lung cancer, and consider how to provide telenursing support.
Basic objectives2 Others
Basic objectives -Others Deeply interpret the case, and consider how to provide telenursing support for older adults with lung cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Symptoms during tele nursing, Participants' Perception and behavior for treatment.
Key secondary outcomes Quality of Life,

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Monitoring of physical and mental condition, assessment of change or exacerbation of physical and mental condition (triage), nursing consultation/health coaching, mentoring, by nurse in remote location.
interventions term: every day for 3months.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Older adults over the age of 65 with stable lung cancer.
Receiving outpatient cancer medicine therapy(chemotherapy).
able to walk and independent of ADL(activities of daily living).
Key exclusion criteria at the end of life.
Persons who can not operate the device by themselves or respond to calls and videophone calls.
Person who receive radiation therapy during intervention.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Tomoyo
Middle name
Last name Harada
Organization St.Luke's International University
Division name Nursing Science Master Course Student.
Zip code 1040044
Address 10-1, akashicho, chuo-ku,Tokyo, Japan.
TEL 03-3543-6391
Email 19mn024@slcn.ac.jp

Public contact
Name of contact person
1st name Tomoyo
Middle name
Last name Harada
Organization St.Luke's International University
Division name Nursing Science Master Course Student.
Zip code 1030004
Address 3-5-13-201, Higashinihombashi, chuo-ku,Tokyo, Japan.
TEL 05053757808
Homepage URL
Email 19mn024@slcn.ac.jp

Sponsor
Institute St.Luke's International University.
Institute
Department

Funding Source
Organization self

other: Ministry of Education, Culture, Sports, Science and Technology, Japan.
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 St.Luke's International University.
Address 10-1, akashicho, chuo-ku,Tokyo, Japan.
Tel 03-5550-2423
Email kenkyukikaku@luke.ac.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
2020 Year 06 Month 04 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 04 Day
Date of IRB
2020 Year 06 Month 11 Day
Anticipated trial start date
2020 Year 06 Month 20 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 04 Day
Last modified on
2020 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046397

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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