UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037875 |
|---|---|
| Receipt number | R000043180 |
| Scientific Title | Verification of the Effectiveness of Educational Programs Leveraging IT which Promote Cervical Cancer Screenings in Women in Their 20s |
| Date of disclosure of the study information | 2019/08/31 |
| Last modified on | 2022/09/02 16:49:44 |
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Basic information
Public title
Verification of the Effectiveness of Educational Programs Leveraging IT which Promote Cervical Cancer Screenings in Women in Their 20s
Acronym
Educational Intervention for the Prevention of Cervical Cancer
Scientific Title
Verification of the Effectiveness of Educational Programs Leveraging IT which Promote Cervical Cancer Screenings in Women in Their 20s
Scientific Title:Acronym
Verification of the Effectiveness of Educational Programs Leveraging IT which Promote Cervical Cancer Screenings in Women in Their 20s
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compared the changes in the awareness in cervical cancer screening knowledge and health belief standards between a group of women in their 20s which took an educational program for cervical cancer prevention and a group which did not.
Furthermore, we evaluated the effectiveness of educational programs toward cervical cancer screening.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health belief standard of cervical cancer and its screening,
Cervical cancer screening
Key secondary outcomes
Knowledge of cervical cancer,
Knowledge of healthy lifestyles,
Whether digital pictures were viewed,
Healthy behaviors during research period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Receive health education and send images after 1 and 6 months.
The survey will be conducted before and after the health class, 6 months and 1 year later.
Interventions/Control_2
Without health education, the survey will be conducted on the day of request, 6 months and 1 year later.
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Women in their 20s who have not married or given birth and not had a cervical cancer screening within the past year
Key exclusion criteria
Women who have had a cervical cancer screening in the past year,
Women who have given birth in the past year,
Medical or nursing students with medical knowledge, female doctors and female nurses
Target sample size
67
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Nakamura |
Organization
Hyogo University
Division name
Faculty of Nursing
Zip code
675-0195
Address
2301 Shinzaike Hiraoka-cho Kakogawa-shi Hyogo-ken
TEL
0794275111
ntomoko@hyogo-dai.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Nakamura |
Organization
Hyogo University
Division name
The Faculty of Nursing
Zip code
675-0195
Address
2301 Shinzaike Hiraoka-cho Kakogawa-shi Hyogo-ken
TEL
079-427-5111
Homepage URL
ntomoko@hyogo-dai.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Hyogo University Osaka Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo University
Address
2301 Shinzaike Hiraoka-cho Kakogawa-shi Hyogo-ken,
Tel
079-427-511
ntomoko@hyogo-dai.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
| 2019 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.researchgate.net/publication/347201268_Verifying_the_Effects_of_an_Education_Program_Lev
Publication of results
Published
Result
URL related to results and publications
Verifying the Effects of an Education Program Leveraging Information Technology to Promote Cervical
Number of participants that the trial has enrolled
287
Results
Main effects were observed in Cervical Cancer Screening (p = 0.00) and Healthy Lifestyles (p = 0.00).Regarding the amount of change from the initial survey, knowledge scores in the Cervical Cancer (p = 0.027) and Cervical Cancer Screening (p = 0.016) categories were significantly higher in the intervention group than in the control group. There was no significant difference in cervical cancer screening rates (p = 0.26) between the two groups.
Results date posted
| 2022 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 30 | Day |
Baseline Characteristics
Unmarried women in their 20s who have not given birth and who have not undergone cervical cancer screening within one year
Participant flow
First time (intervention group 142 control group 145)
6 months later (intervention group 37 control group 30)
1 year post-survey (intervention group 33 control group 27)
Adverse events
Nothing
Outcome measures
The Japanese version of the Health Belief Model Scale for Cervical Cancer and the Pap Smear Test (HBMSCCPST), knowledge scores in the categories of Healthy Lifestyles, Cervical Cancer, Cervical Cancer Screening, and screening behavior.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043180
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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