UMIN-CTR Clinical Trial

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
Institute	Keio University Graduate School of Health Management
Institute
Department

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
URL(English)	https://upload.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

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