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UMIN-CTR Clinical Trial |
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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 |
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
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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
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Scientific Title:Acronym | Telehome Monitoring-based Telenursing for Older Adults with Lung Cancer | |
Region |
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Condition | |||
Condition | Lung Cancer | ||
Classification by specialty |
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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 |
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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. |
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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 |
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Age-upper limit |
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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). |
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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. |
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Target sample size | 3 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |