UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of an E-Learning Program for Oncology Nurses Regarding Fertility Preservation for Breast Cancer Patients: A Pilot Study
Title of the study (Brief title)	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	Tomo Fujiwara
Organization	St.Luke's International University,Graduate School
Division name	Nursing
Address	10-1 Akashi-cho,Chuo-ku,Tokyo
TEL	0335436391
Email	slcn-16mn025@umin.ac.jp

Public contact
Name of contact person	Tomo Fujiwara
Organization	St.Luke's International University,Graduate School
Division name	Nursing
Address	10-1 Akashi-cho,Chuo-ku,Tokyo
TEL	0335436391
Homepage URL
Email	slcn-16mn025@umin.ac.jp

Sponsor
Institute	St.Luke's International University,Graduate School
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040589