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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029894
Receipt No. R000034136
Scientific Title Alleviating psychological effects of positive cervical cancer screening result notification: a randomized controlled trial
Date of disclosure of the study information 2017/11/27
Last modified on 2018/04/06

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Basic information
Public title Alleviating psychological effects of positive cervical cancer screening result notification: a randomized controlled trial
Acronym Alleviating psychological effects of positive cervical cancer screening result notification: a randomized controlled trial
Scientific Title Alleviating psychological effects of positive cervical cancer screening result notification: a randomized controlled trial
Scientific Title:Acronym Alleviating psychological effects of positive cervical cancer screening result notification: a randomized controlled trial
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of result notification about screening on psychological effect and intention to further examination of cervical cancer screening
Basic objectives2 Others
Basic objectives -Others To evaluate the effect of screening result notification
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Psychological distress
Key secondary outcomes intention to further examination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
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 7
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 We showed an leaflet containing basic information about the disease, advantages, disadvantages, and method of complete examination to the women who received screen-positive result (not show cytologic diagnosis) in a virtual situation. Then, we observed the psychological distress level and intention to further examination among them.
Interventions/Control_2 We showed an leaflet containing basic information about the disease, advantages, disadvantages, and method of complete examination to the women who received screen-positive result (cytologic diagnosis:NILM) in a virtual situation. Then, we observed the psychological distress level and intention to further examination among them.
Interventions/Control_3 We showed an leaflet containing basic information about the disease, advantages, disadvantages, and method of complete examination to the women who received screen-positive result (cytologic diagnosis: ASC-US) in a virtual situation. Then, we observed the psychological distress level and intention to further examination among them.
Interventions/Control_4 We showed an leaflet containing basic information about the disease, advantages, disadvantages, and method of complete examination to the women who received screen-positive result (cytologic diagnosis: ASC-H) in a virtual situation. Then, we observed the psychological distress level and intention to further examination among them.
Interventions/Control_5 We showed an leaflet containing basic information about the disease, advantages, disadvantages, and method of complete examination to the women who received screen-positive result (LSIL) in a virtual situation. Then, we observed the psychological distress level and intention to further examination among them.
Interventions/Control_6 We showed an leaflet containing basic information about the disease, advantages, disadvantages, and method of complete examination to the women who received screen-positive result (cytologic diagnosis: HSIL) in a virtual situation. Then, we observed the psychological distress level and intention to further examination among them.
Interventions/Control_7 We showed an leaflet containing basic information about the disease, advantages, disadvantages, and method of complete examination to the women who received screen-positive result (cytologic diagnosis: SCC) in a virtual situation. Then, we observed the psychological distress level and intention to further examination among them.
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
69 years-old >=
Gender Female
Key inclusion criteria Women aged 20-69 years who have participated in the screening
Key exclusion criteria No
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Ichikawa
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tenno-dai Tsukuba Ibaraki Japan 305-8575
TEL 029-853-3423
Email masao@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukari Isaka
Organization University of Tsukuba
Division name Graduate School of Comprehensive Human Sciences
Zip code
Address 1-1-1 Tenno-dai Tsukuba Ibaraki Japan 305-8575
TEL 029-853-3496
Homepage URL
Email s1530359@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Non
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
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
2017 Year 11 Month 27 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
2017 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 27 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 11 Month 09 Day
Last modified on
2018 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034136

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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