UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056206 |
|---|---|
| Receipt number | R000064184 |
| Scientific Title | An intervention study on promoting uptake of cervical cancer screening among female university students based on the health behavior theory |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/05/22 23:36:18 |
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Basic information
Public title
An intervention study on promoting uptake of cervical cancer screening among female university students
Acronym
An intervention study on promoting uptake of cervical cancer screening among female university students
Scientific Title
An intervention study on promoting uptake of cervical cancer screening among female university students based on the health behavior theory
Scientific Title:Acronym
An intervention study on promoting uptake of cervical cancer screening among female university students based on the health behavior theory
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of an intervention based on health behavior theory on promoting uptake of cervical cancer screening among female students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
uptake of cervical cancer screening (before intervention, immediately after intervention, and 1 month later)
Key secondary outcomes
Psychological variables related to cervical cancer screening (Subjective norm, prototype similarity, self-efficacy, action planning, intention for uptake of cervical cancer screening, willingness, stages of change)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention 1: Intervention to improve subjective norms
Participants read a statement that the significant others agree with their uptaking cervical cancer screening.
Interventions/Control_2
Intervention 2: Intervention to improve prototype similarity
Participants read a profile of a typical person who has uptaken cervical cancer screening.
Interventions/Control_3
Intervention 3: Intervention to improve self-efficacy
Participants are provided information about cervical cancer and cervical cancer screening, watch a video of others uptaking of cervical cancer screening, and then hear about the stories of others who have been uptaking cervical cancer screening.
Interventions/Control_4
Intervention 4: Intervention to improve action planning
Participants develop a behavioral plan for when, where, and how they will uptake cervical cancer screening. After making the plan, they will obtain feedback from the experimenter on the plan and modify it.
Interventions/Control_5
Control group: filler task
Participants read a statement recommending regular health checkups.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
Female students aged 20-24 attending a 4-year university in the Kanto area
Key exclusion criteria
Age, biological sex
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Azusa |
| Middle name | |
| Last name | Saito |
Organization
Sophia University
Division name
Faculty of Human Sciences, Department of Psychology
Zip code
102-8554
Address
Kioi-cho, Chiyoda-ku, Tokyo
TEL
03-3238-3811
az_saito@sophia.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Haruta |
Organization
Graduate school of Sophia University
Division name
Faculty of Human Sciences, Department of Psychology
Zip code
102-8554
Address
Kioi-cho, Chiyoda-ku, Tokyo
TEL
03-3238-3811
Homepage URL
https://osf.io/xr6dn/
haruta.psychresearch@gmail.com
Sponsor or person
Institute
Sophia University
Institute
Department
Personal name
Azusa Saito
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mitsuru Hisata, Rissho university, Faculty of Psychology, Department of Clinical Psychology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sophia University
Address
7-1 Kioi-cho, Chiyoda-ku, Tokyo
Tel
03-3238-3173
rhs-rinri-co@sophia.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
| 2025 | Year | 01 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064184
