UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040654 |
|---|---|
| Receipt number | 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 | 2022/06/06 18:50:26 |
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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
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
19mn024@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046397
