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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name