UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059858 |
|---|---|
| Receipt number | R000068451 |
| Scientific Title | Development and Feasibility of a Nursing Education Program to Enhance Rehabilitation Nursing Skills for Patients with Brain Tumors: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/11/22 |
| Last modified on | 2025/11/22 17:00:01 |
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Basic information
Public title
Development and Feasibility of a Nursing Education Program to Enhance Rehabilitation Nursing Skills for Patients with Brain Tumors: A Pilot Randomized Controlled Trial
Acronym
Development and Feasibility of a Nursing Education Program to Enhance Rehabilitation Nursing Skills for Patients with Brain Tumors: A Pilot Randomized Controlled Trial
Scientific Title
Development and Feasibility of a Nursing Education Program to Enhance Rehabilitation Nursing Skills for Patients with Brain Tumors: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Development and Feasibility of a Nursing Education Program to Enhance Rehabilitation Nursing Skills for Patients with Brain Tumors: A Pilot Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Nurses who provide care for patients with primary malignant brain tumor
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop an educational program to support nurses in acquiring rehabilitation nursing skills for patients with brain tumors, and to: (1) evaluate the feasibility of recruitment, randomization, and outcome assessment in preparation for a future randomized controlled trial; (2) identify potential mechanisms through which the educational program may exert its effects; and (3) obtain preliminary estimates of effect size to inform the design of a future RCT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility assessment
Key secondary outcomes
1) trends in the mechanisms through which the developed nursing education program exerts its effects; and 2) indicators of effect size
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participation in the nursing education program
Interventions/Control_2
no participation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Nurses working at a designated cancer care collaborative hospital with the functions of an acute care hospital in the Kanto region
2) Nurses currently working in a neurosurgical ward or a neuro-oncology ward
3) Nurses with less than six years of nursing experience in caring for patients with brain tumors
Key exclusion criteria
1) Nurse managers or other administrative staff who are not involved in direct patient care
2) Nurses who may be transferred, resign, or change departments during the intervention period
3) Nurses who hold specialist qualifications, such as Certified Nurse Specialists (CNS) or Certified Nurses (CN)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Runa |
| Middle name | |
| Last name | Tokunaga |
Organization
Sophia University
Division name
Department of Nursing, Faculty of Human Sciences
Zip code
161-8550
Address
4-16-11, Shimoochiai, Shinjuku-ku, Tokyo, Japan
TEL
03-3950-6147
r-tokunaga@sophia.ac.jp
Public contact
Name of contact person
| 1st name | Runa |
| Middle name | |
| Last name | Tokunaga |
Organization
Sophia University
Division name
Department of Nursing, Faculty of Human Sciences
Zip code
161-8550
Address
4-16-11, Shimoochiai, Shinjuku-ku, Tokyo, Japan
TEL
03-3950-6147
Homepage URL
r-tokunaga@sophia.ac.jp
Sponsor or person
Institute
Sophia University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
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
r-tokunaga@sophia.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068451
