UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035739 |
|---|---|
| Receipt number | R000040589 |
| Scientific Title | Development of an E-Learning Program for Oncology Nurses Regarding Fertility Preservation for Breast Cancer Patients: A Pilot Study |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/02/01 13:56:23 |
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Basic information
Public title
Development of an E-Learning Program for Oncology Nurses
Regarding Fertility Preservation for Breast Cancer Patients: A Pilot Study
Acronym
Development of an E-Learning Program for Oncology Nurses
Regarding Fertility Preservation for Breast Cancer Patients: A Pilot Study
Scientific Title
Development of an E-Learning Program for Oncology Nurses
Regarding Fertility Preservation for Breast Cancer Patients: A Pilot Study
Scientific Title:Acronym
Development of an E-Learning Program for Oncology Nurses
Regarding Fertility Preservation for Breast Cancer Patients: A Pilot Study
Region
| Japan |
Condition
Condition
Nurses in charge of breast cancer patients
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is a pilot study to develop e-learning educational materials for nurses about fertility preservation for breast caner patients , and to measure the educational effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change rate of Nurse's knowledge and attitude after one week compared with data before intervention
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Subjects will attend a week-long educational e-learning program regarding fertility preservation for breast cancer 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
Nurses who meet criteria below; 1) Nurses who take care of breast cancer patients at the Cancer hospitals in the Kanto area. 2)Nurses who work at outpatient or inpatient wards. 3)Nurses who take charge of cancer patients for more than 3 years and have clinical experience of 3 years and more. 4)Nurses who agreed to participate in this research.
Key exclusion criteria
Exclusion criteria are novice nurses.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomo Fujiwara |
Organization
St.Luke's International University,Graduate School
Division name
Nursing
Zip code
Address
10-1 Akashi-cho,Chuo-ku,Tokyo
TEL
0335436391
slcn-16mn025@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomo Fujiwara |
Organization
St.Luke's International University,Graduate School
Division name
Nursing
Zip code
Address
10-1 Akashi-cho,Chuo-ku,Tokyo
TEL
0335436391
Homepage URL
slcn-16mn025@umin.ac.jp
Sponsor or person
Institute
St.Luke's International University,Graduate School
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
Address
Tel
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
聖路加国際病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | 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
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040589
