UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049308 |
|---|---|
| Receipt number | R000056149 |
| Scientific Title | Verification of the synergistic effect of the cancer screening recommendation video and the individual recall to improve cancer screening rate |
| Date of disclosure of the study information | 2022/10/26 |
| Last modified on | 2022/10/24 20:02:11 |
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Basic information
Public title
Verification of the synergistic effect of the cancer screening recommendation video and the individual recall to improve cancer screening rate
Acronym
RCT of the synergistic effect of the cancer screening video and the individual recall
Scientific Title
Verification of the synergistic effect of the cancer screening recommendation video and the individual recall to improve cancer screening rate
Scientific Title:Acronym
RCT of the synergistic effect of the cancer screening video and the individual recall
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to improve the cancer screening rate, we have developed a new method using the recommendation video in conjunction with an individual recall by local governments including specific instructions on how to obtain cancer screening. The purpose of this randomized controlled trial is to examine the effectiveness of this method in improving the screening rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Breast cancer screening rates after the recall
Key secondary outcomes
Annual breast cancer screening rate, age-specific screening rate, screening rate according to past screening history
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
cancer screening recommendation video and individual recall
Interventions/Control_2
individual recall
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 40-69 residing in eligible municipalities who were eligible for breast cancer screening in FY2022, but whose screening was not confirmed as of September
Key exclusion criteria
None
Target sample size
21818
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Yamamoto |
Organization
National Cancer Center
Division name
Institute for Cancer Control
Zip code
1040045
Address
5-1-1. Tsukiji, Chuo, Tokyo
TEL
+81335422511
siyamamo@ncc.go.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Yamamoto |
Organization
National Cancer Center
Division name
Institute for Cancer Control
Zip code
1040045
Address
5-1-1. Tsukiji, Chuo, Tokyo
TEL
+81335422511
Homepage URL
siyamamo@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1, Tsukiji, Chuo, Tokyo
Tel
+81335422511
NCC_IRBoffice@ml.res.ncc.go.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
八王子市
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056149
