UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053545 |
|---|---|
| Receipt number | R000060872 |
| Scientific Title | Verification of the effectiveness of an educational program aimed at alleviating nurses' difficulties in communication regarding death with cancer patients at the end-of-life stage |
| Date of disclosure of the study information | 2024/02/10 |
| Last modified on | 2024/02/05 15:17:10 |
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Basic information
Public title
Verification of the effectiveness of an educational program aimed at alleviating nurses' difficulties in communication regarding death with cancer patients at the end-of-life stage
Acronym
Communication nursing education program
Scientific Title
Verification of the effectiveness of an educational program aimed at alleviating nurses' difficulties in communication regarding death with cancer patients at the end-of-life stage
Scientific Title:Acronym
Communication nursing education program
Region
| Japan |
Condition
Condition
Nurse
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effectiveness of an educational program aimed at alleviating nurses' difficulties in communication regarding death with cancer patients at the end-of-life stage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual Analogue Scale; confusion about communication, nervousness, desire to avoid communication, confidence, motivation
Key secondary outcomes
Frommelt Attitude Toward Care of Dying Scale, Form B in Japanese
Nurses' difficulty with cancer care
Difficulties encountered by nurses in the care of terminally ill cancer patients in general hospitals
Subjective changes in communication difficulties, motivation, and behavior with end-of-life stage cancer patients, etc
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
The intervention group will take the 6-month communication education program.
The program includes on-demand lectures, communication role plays, process records, and group work.
Interventions/Control_2
Control group
The control group will not take the communication education program.
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) Work at a target facility
2) 2 years or more of cancer nursing experience
3) Nurses providing care to end-of-life stage cancer patients
End-of-life stage cancer patients are generally expected to have a prognosis of less than one year, and this includes patients receiving palliative treatments such as chemotherapy and radiation therapy that are not intended to be a complete cure.
Key exclusion criteria
Those who have difficulty participating in research due to psychological reasons such as anxiety or social reasons such as time constraints.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Kyota |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8930
akyota@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Kyota |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8930
Homepage URL
akyota@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Gunma University Graduate School of Health Sciences
IRB Contact (For public release)
Organization
Gunma University Graduate School of Health Sciences
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-8930
akyota@gunma-u.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
| 2024 | Year | 02 | Month | 10 | 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
| 2024 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | 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
| 2024 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060872
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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