UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017797
Receipt number R000020566
Scientific Title Development of Health Education program about breast awareness using Health Belief Model for nursing students.
Date of disclosure of the study information 2015/06/04
Last modified on 2016/02/29 22:16:56

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Basic information

Public title

Development of Health Education program about breast awareness using Health Belief Model for nursing students.

Acronym

Development of Health Education program about breast awareness using Health Belief Model for nursing students.

Scientific Title

Development of Health Education program about breast awareness using Health Belief Model for nursing students.

Scientific Title:Acronym

Development of Health Education program about breast awareness using Health Belief Model for nursing students.

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Nursing Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to develop education program using Health Belief Model to raise interest in breast awareness for nursing students in university.

Basic objectives2

Others

Basic objectives -Others

To help students to have breast awareness

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Created a scale based on the "Healh Belief Model Scale"

Key secondary outcomes

1)knowledge test
2)the change of behaviour and belief of breast cancer and breast


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

program consist of lecture and group work

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1)female nursing students.
2)submitted written consent as a participant

Key exclusion criteria

Person who is classfied by the researcher that she is not eligible for this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masako Kaneko

Organization

Keio University

Division name

Graduate School of Health Management

Zip code


Address

4411 Endo, Fujisawa-shi, Kanagawa

TEL

0466-49-6222

Email

masapooh@sfc.keio.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junko Odake

Organization

Keio University

Division name

Graduate School of Health Management

Zip code


Address

4411 Endo, Fujisawa-shi, Kanagawa

TEL

0466-49-6222

Homepage URL


Email

jodake@sfc.keio.ac.jp


Sponsor or person

Institute

Keio University Graduate School of Health Management

Institute

Department

Personal name



Funding Source

Organization

nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 04 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

Completed

Date of protocol fixation

2015 Year 06 Month 03 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 05 Day

Last follow-up date

2015 Year 11 Month 30 Day

Date of closure to data entry

2015 Year 11 Month 30 Day

Date trial data considered complete

2015 Year 11 Month 30 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 06 Month 03 Day

Last modified on

2016 Year 02 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name