UMIN-CTR Clinical Trial

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
Email	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
Email	ntomoko@hyogo-dai.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043180