UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050944 |
|---|---|
| Receipt number | R000058068 |
| Scientific Title | Effectiveness of Telemonitoring-based Telenursing on Health Outcomes for People with Lung Cancer and Its Relations to Their Health Management Process: A Mixed Methods Research with Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/04/27 |
| Last modified on | 2025/04/30 09:02:37 |
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Basic information
Public title
Effectiveness of Telemonitoring-based Telenursing on Health Outcomes for People with Lung Cancer and Its Relations to Their Health Management Process: A Mixed Methods Research with Randomized Controlled Trial
Acronym
Telemonitoring-based Telenursing for People with Lung Cancer: A Mixed Methods Research with Randomized Controlled Trial
Scientific Title
Effectiveness of Telemonitoring-based Telenursing on Health Outcomes for People with Lung Cancer and Its Relations to Their Health Management Process: A Mixed Methods Research with Randomized Controlled Trial
Scientific Title:Acronym
Telemonitoring-based Telenursing for People with Lung Cancer: A Mixed Methods Research with Randomized Controlled Trial
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled trial is conducted to examine the effectiveness of telemonitoring-based telenursing for people with lung cancer, as well as to understand participants' qualitative health management process and to examine whether these quantitative and qualitative outcomes are related using mixed research methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of detection of signs of deteriorating health conditions.
Key secondary outcomes
number of detection of signs of deteriorating health conditions, unscheduled clinic visits, Unscheduled hospitalization, quality of life, symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subjects will enter the daily vital signs, symptoms, and other medical interview items into a tablet terminal, and send it to the nursing monitoring center, and nurses will monitor the received data, triage of physical and psychological conditions, and provide nursing consultation or guidance and telementoring for three months.
Interventions/Control_2
Receive only conventional face-to-face care. Distribution of self-health record booklets
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Outpatients with lung cancer who are undergoing chemotherapy or within one year of chemotherapy
2) Those who have been diagnosed with lung cancer and are accepting treatment
3) Those who receive regular medical care from a physician and have the consent of the physician in charge to participate in this study
4) Performance Status Score: 0-2
5) Persons who are able to take daily vital signs and other measurements and answer the questionnaire items, and who can understand the operation of the terminal.
Key exclusion criteria
Persons who meet any of the following criteria
1) End-of-life
2) Patients with cognitive decline who have difficulty in self-care and verbal communication
3) Patients who require hospitalization for lung cancer during the intervention period.
4)Persons who do not understand the operation of the terminal and have no alternative
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Tomoyo |
| Middle name | |
| Last name | Harada |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1, Akashi-chou, Chuo-ku, Tokyo
TEL
03-5550-2362
21dn010@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
Graduate School of Nursing Science
Zip code
1040044
Address
10-1, Akashi-chou, Chuo-ku, Tokyo
TEL
03-5550-2362
Homepage URL
21dn010@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of St. Luke's International University
Address
10-1, Akashi-chou, Chuo-ku, Tokyo
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
| 2023 | Year | 04 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 04 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058068
