UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057300 |
|---|---|
| Receipt number | R000065501 |
| Scientific Title | Development of a rehabilitation nursing education program for brain tumor patients and verification of its feasibility: Feasibility study |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/09/15 09:31:20 |
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Basic information
Public title
Development of a rehabilitation nursing education program for brain tumor patients and verification of its feasibility: Feasibility study
Acronym
Development of a rehabilitation nursing education program for brain tumor patients and verification of its feasibility: Feasibility study
Scientific Title
Development of a rehabilitation nursing education program for brain tumor patients and verification of its feasibility: Feasibility study
Scientific Title:Acronym
Development of a rehabilitation nursing education program for brain tumor patients and verification of its feasibility: Feasibility study
Region
| Japan |
Condition
Condition
Primary brain tumor patients
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to 1) verify the mechanism by which education is effective, and 2) evaluate the feasibility of the proposed nursing education program that has been created so far and is focused on rehabilitation nursing for brain tumor patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Changes in variables measuring behavior before and after the intervention
2) Causal relationships between "behavior" and other constructs of the theory of planned behavior
3) Relationships between basic attributes of research subjects and each score
Key secondary outcomes
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
| Other |
Interventions/Control_1
A tentative nursing education program to promote rehabilitation nursing for brain tumor patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants will meet all of the following criteria:
1) Nurses working at cancer treatment hospitals in Tokyo
2) Nurses currently working in neurosurgery wards or brain and spinal cord oncology wards
3) Nurses with less than six years of experience nursing brain tumor patients
4) There will be no restrictions on qualifications
5) No physical or mental problems that would prevent them from participating in the interviews
6) Nurses who understand the purpose, content, and ethical considerations of this study and have provided written consent
Key exclusion criteria
Those who meet any of the following criteria will not be included in this study.
1) Nurses in managerial positions such as head nurses who are not involved in direct patient care
2) Nurses who may be transferred to another department, resign, or change jobs during the intervention period.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Runa |
| Middle name | |
| Last name | Tokunaga |
Organization
St Luke's International University
Division name
Graduate School of Nursing Doctoral Program
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
04-2995-1211
23dn011@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Runa |
| Middle name | |
| Last name | Tokunaga |
Organization
St Luke's International University
Division name
Graduate School of Nursing Doctoral Program
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
04-2995-1211
Homepage URL
23dn011@slcn.ac.jp
Sponsor or person
Institute
St Luke's International University
Institute
Department
Personal name
Funding Source
Organization
St Luke's International University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St Luke' International University
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
03-3543-6391
23dn011@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
| 2025 | Year | 03 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2025 | Year | 03 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065501
