UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045424 |
|---|---|
| Receipt number | R000050976 |
| Scientific Title | Development and evaluation of enlightenment programs on breast and cervical cancer screening attendance: cluster randomized controlled trial in occupational field |
| Date of disclosure of the study information | 2021/09/08 |
| Last modified on | 2021/09/06 10:58:45 |
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Basic information
Public title
Development and evaluation of enlightenment programs on breast and cervical cancer screening attendance: cluster randomized controlled trial in occupational field
Acronym
Development and evaluation of enlightenment programs on breast and cervical cancer screening attendance: cRCT
Scientific Title
Development and evaluation of enlightenment programs on breast and cervical cancer screening attendance: cluster randomized controlled trial in occupational field
Scientific Title:Acronym
Development and evaluation of enlightenment programs on breast and cervical cancer screening attendance: cRCT
Region
| Japan |
Condition
Condition
breast cancer and cervical cancer
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of different information sources on increasing knowledge and screening attendance of breast and cervical cancer by cluster randomized controlled study, and to evaluate the cost-effectiveness and ripple effect of enlightenment programs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Breast cancer screening within 2 years after intervention
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
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Control
Interventions/Control_2
Distributing leaflet about breast and cervical cancer screening
Interventions/Control_3
Distributing comic books about breast cancer screening
Interventions/Control_4
Distributing leaflets and/or comic books about breast and cervical cancer screening
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
| 63 | years-old | >= |
Gender
Female
Key inclusion criteria
Female employees with consent to participate in research at 120 stores of a company
Key exclusion criteria
Not applicable
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Miyamatsu |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2355
miyan@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Miyamatsu |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2355
Homepage URL
miyan@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu city, Shiga, Japan
Tel
077-548-3576
hqrec@belle.shiga-med.ac.jp
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
| 2021 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050976
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050976
Number of participants that the trial has enrolled
4431
Results
A combination of basic and emotional information with a subsidy application form was found to be effective for encouraging breast cancer screening attendance among never-screened female employees.
Results date posted
| 2021 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese female employees (mean age 47.4 years)
Participant flow
consent: 4413
intervention in 2013: 3680
complete post intervention survey in 2014: 3400
Adverse events
No adverse effect reported
Outcome measures
Breast cancer screening attendance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050976
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/09/08 | protocol.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/09/08 | CRF.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/09/08 | 研究症例データ.docx |
