UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029894 |
|---|---|
| Receipt number | 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 | 2019/09/10 14:15:21 |
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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
| Obstetrics 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
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
intervention group:
participants showed an information leaflet containing basic information about the disease, advantages, disadvantages, and method of complete examination.
The participants received a hypothetical screening result: positive or negative. In case of a positive result, the participants were informed of their hypothetical cytological stage, one of the five grades based on the Bethesda System (TBS), or not informed of the stage. Thus, there were six patterns of positive results, plus a negative result.
Interventions/Control_2
control group:
participants showed the notification of cancer screening result that current local government uses.
The participants received a hypothetical screening result: positive or negative. In case of a positive result, the participants were informed of their hypothetical cytological stage, one of the five grades based on the Bethesda System (TBS), or not informed of the stage. Thus, there were six patterns of positive results, plus a negative result.
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
| 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
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
s1530359@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
| 2019 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034136
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
