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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030465
Receipt No. R000034731
Scientific Title Evaluation of the encouragement methods to have breast cancer screening: cluster randomized controlled trial in occupational field
Date of disclosure of the study information 2018/01/06
Last modified on 2017/12/19

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Basic information
Public title Evaluation of the encouragement methods to have breast cancer screening: cluster randomized controlled trial in occupational field
Acronym Evaluation of the encouragement methods to have breast cancer screening: cRCT
Scientific Title Evaluation of the encouragement methods to have breast cancer screening: cluster randomized controlled trial in occupational field
Scientific Title:Acronym Evaluation of the encouragement methods to have breast cancer screening: cRCT
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of intervention to encouragement to have breast cancer screening test on screening rate and other health prone behaviours
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes History of screening of breast cancer in the past 2 years
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Providing opportunity of mammography screening at work-site by examination car
Interventions/Control_2 Distributing leaflets about breast cancer screening
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
40 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria Female employees with consent to participate in research at 25 out of 150 stores of the company under study
Key exclusion criteria 1) Past history of breast cancer
2) In pregnancy
3) In breast-feeding
Target sample size 2100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naomi Miyamatsu
Organization Shiga University of Medical Science
Division name Departmento of Clinical Nursing
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2355
Email miyan@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Miyamatsu
Organization Shiga University of Medical Science
Division name Departmento of Clinical Nursing
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2355
Homepage URL
Email miyan@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Ministry of Education,Culture,Sports,Science and Technology,Japan
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 06 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 11 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 05 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
2017 Year 12 Month 19 Day
Last modified on
2017 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034731

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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