UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039124 |
|---|---|
| Receipt number | R000044620 |
| Scientific Title | Examination of effectiveness of study group on adverse event evaluation of radiology ward nurses Comparison of Grade Evaluation using CTCAE v.4.0 before and after the study session |
| Date of disclosure of the study information | 2020/01/17 |
| Last modified on | 2020/01/10 19:38:08 |
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Basic information
Public title
Examination of effectiveness of study group on adverse event evaluation of radiology ward nurses
Comparison of Grade Evaluation using CTCAE v.4.0 before and after the study session
Acronym
Examination of effectiveness of study group on adverse event evaluation of radiology ward nurses
Comparison of Grade Evaluation using CTCAE v.4.0 before and after the study session
Scientific Title
Examination of effectiveness of study group on adverse event evaluation of radiology ward nurses
Comparison of Grade Evaluation using CTCAE v.4.0 before and after the study session
Scientific Title:Acronym
Examination of effectiveness of study group on adverse event evaluation of radiology ward nurses
Comparison of Grade Evaluation using CTCAE v.4.0 before and after the study session
Region
| Japan |
Condition
Condition
Nursing research
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is said that nurses involved in cancer nursing are required to understand treatment and acquire skills to handle adverse events, and assessment and care for acute adverse events are the most important of radiotherapy among nurses. One of the important roles.
We conducted a grading test using CTCAE v.4.0 in Radiodermatitis and Oral mucositis to know the current status of Grade evaluation for nurses in this radiology ward. It is clear that there is a possibility that Grade evaluation is based on variability and vague knowledge. It is suggested that it is necessary to conduct regular study sessions and tests on Grade Evaluation of CTCAEv4.0 as future work.
Radiation dermatitis is pain caused by redness and wrinkles, and oral mucositis is often painful and difficult to take orally, which may significantly lower the patient's QOL. Radiation dermatitis and oral mucositis cannot be evaluated numerically, and ambiguous expressions such as mild and moderate are used. It is thought to affect the evaluation. Therefore, it was necessary to acquire basic knowledge and to have a common understanding of evaluation criteria, and the study group was considered effective.
Therefore, in this study, grading tests and learning before and after the study session on grade evaluation of CTCAEv4.0 in adverse events of radiodermatitis and oral mucositis that are regularly evaluated for nurses in the radiology ward. I would like to investigate the effectiveness of conducting a study meeting by conducting a questionnaire after the meeting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis method
Compare the average values of test1 and test2 with the corresponding t test.
Null hypothesis H0
Average values of test 1 and test 2 are the same
Alternative hypothesis H1
Test 1 and Test 2 have different average values (Test 2 has a higher average value)
Significance level is 5% and two-sided test.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
onducted a grading study session on radioactive dermatitis and oral mucositis using CTCAEv4.0, followed by a grading test before and after the study session. Conducted a questionnaire on satisfaction and understanding of the study group. Analyze and evaluate response rate changes and questionnaires before and after the study session.
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
Gunma University Hospital, North Ward, 6th floor Radiology Ward, 23 nurses.
In addition, it is a condition that it is possible to participate in the study group among the subjects who have obtained consent.
Key exclusion criteria
During the survey period, excluding research associates, cancer radiotherapy certified nurses, and short-time workers who belong to the ward on the 6th floor of Gunma University Hospital
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Manami |
| Middle name | |
| Last name | Nakamura |
Organization
Gunma University Hospital
Division name
North Ward, 6th floor
Zip code
371-8511
Address
3-15-15 Showacho, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8389
manamina@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Takayama |
Organization
Gunma University Hospital
Division name
North Ward, 6th floor
Zip code
371-8511
Address
3-15-15 Showacho, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8389
Homepage URL
manamina@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University Hospital
Address
3-15-15 Showacho, Maebashi, Gunma 371-8511, Japan
Tel
027-220-8389
r-takayama@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
| 2020 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2020 | 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
| 2020 | Year | 01 | Month | 10 | Day |
Last modified on
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044620
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