UMIN-CTR Clinical Trial

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	non URL
Publication of results	Unpublished

Result
URL related to results and publications	https://luke.repo.nii.ac.jp/?action=pages_view_main&active_action=repository_view_main_item_detail&i
Number of participants that the trial has enrolled	2
Results	One 88-year-old woman and one 72-year-old man were included in the study. Trigger symptoms tended to be scarce, but there was an association between quantitative changes in step count and subjective physical condition. The subject was living a life of recuperation while maintaining and improving her mental QOL by gaining a better understanding of her body through daily measurements and connecting with a remote nurse, and by gaining a sense of security.
Results date posted	2022 Year 06 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	88-year-old female and 72-year-old male homebound with lung cancer.
Participant flow	Completed a three-month intervention.
Adverse events	non
Outcome measures	A relationship between the number of steps taken and subjective physical condition was observed, suggesting that changes in the subject's physical condition manifested as quantitative fluctuations in the number of steps taken. It was interpreted that the subjects deepened their understanding of their bodies through telenursing and made proactive efforts related to the trigger items to help them manage their physical condition. In addition, the mental QOL was generally maintained and improved, and the subject was living a life of recuperation with a sense of security in being watched over.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046397