UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052220 |
|---|---|
| Receipt number | R000059602 |
| Scientific Title | Impact of the educational program of mesothelioma ABC care program for nurses:Randomized Control Trial |
| Date of disclosure of the study information | 2023/11/25 |
| Last modified on | 2024/03/21 10:52:08 |
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Basic information
Public title
Impact of the educational program of mesothelioma ABC care program for nurses:Randomized Control Trial
Acronym
Impact of the educational program of mesothelioma ABC care program for nurses:Randomized Control Trial
Scientific Title
Impact of the educational program of mesothelioma ABC care program for nurses:Randomized Control Trial
Scientific Title:Acronym
Impact of the educational program of mesothelioma ABC care program for nurses:Randomized Control Trial
Region
| Japan |
Condition
Condition
Malignant Pleural Mesothelioma
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the educational program about care coordination of patients with malignant pleural mesothelioma for nurses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Confident of care coordination of the MPM patients
Key secondary outcomes
Attitude toward the care coordination of the MPM patients
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Educational Program(Care care guide, video and workshop)
Interventions/Control_2
No intervention
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)who have nursing license
2)Who understand Japanese language
3)who can join the pre-study as well as workshop.
4)who can answer the pre and post questionnaires.
5)who would like to join this study
Key exclusion criteria
None
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Nagamatsu |
Organization
St. Luke's International University
Division name
College of Nursing
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-5550-2262
sarah-nagamatsu@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Nagamatsu |
Organization
St. Luke's International University
Division name
College of Nursing
Zip code
1040044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
0355502262
Homepage URL
sarah-nagamatsu@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Yasuko Nagamatsu
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Lue's International University, Research Ethic Comnmittee
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
Tel
03-3543-6391
kenkyukikaku@slcn.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 | 11 | Month | 25 | 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
60
Results
There was significant improvement of confidence, attitude and knowledge regarding care of pleural malignant mesothelioma in Intervention group but not in Control group.
Results date posted
| 2024 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Person who have Japanese license of Nursing
Participant flow
Adverse events
None
Outcome measures
confidence, attitude and knowledge regarding care of pleural malignant mesothelioma
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059602
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
