UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055866 |
|---|---|
| Receipt number | R000063850 |
| Scientific Title | A Randomized Controlled Pilot Study of Video Conferencing Versus On-Demand Video in Providing Information on Hereditary Breast and Ovarian Cancer |
| Date of disclosure of the study information | 2024/10/17 |
| Last modified on | 2024/10/17 20:40:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Randomized Controlled Pilot Study of Video Conferencing Versus On-Demand Video in Providing Information on Hereditary Breast and Ovarian Cancer
Acronym
A Randomized Controlled Pilot Study of Video Conferencing Versus On-Demand Video in Providing Information on Hereditary Breast and Ovarian Cancer
Scientific Title
A Randomized Controlled Pilot Study of Video Conferencing Versus On-Demand Video in Providing Information on Hereditary Breast and Ovarian Cancer
Scientific Title:Acronym
A Randomized Controlled Pilot Study of Video Conferencing Versus On-Demand Video in Providing Information on Hereditary Breast and Ovarian Cancer
Region
| Japan |
Condition
Condition
Hereditary Breast and Ovarian Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A pilot study to provide information on HBOC via video calls or on-demand video viewing, and to collect data to estimate acceptability and feasibility, as well as eligibility criteria and sample size for subjects in future randomized controlled trials.
Basic objectives2
Others
Basic objectives -Others
Feasibility and acceptance study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility and Acceptability(Before provision of information, immediately after the provision of information, and one month later)
Key secondary outcomes
Knowledge of BRCA1/2, concerns, satisfaction, problems with intervention, time spent, questions, future plans
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provide information on HBOC using video calls (Zoom)
Interventions/Control_2
Provide information on HBOC using on-demand videos (Youtube).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Research subjects must meet the conditions in (1) or (2) and all of the eligibility criteria in (3) and beyond.
(1) Female patients diagnosed with breast cancer before 2020
(2) Female patients with a third-degree relative diagnosed with breast cancer at any time in the past.
(3) Patients aged 18 years or older at the time of obtaining consent
(4) Those who can communicate in Japanese
(5) Those who have a computer, tablet or smartphone and can connect to the internet
(6) Those who have obtained written consent from the person themselves to participate in the research via Google Forms
Key exclusion criteria
The following criteria will be used to exclude participants.
(1) Patients who have received medical treatment for a diagnosis or suspicion of HBOC, or their blood relatives (regardless of the degree of relatedness)
(2) Those who have received information about HBOC from a medical care provider.
(3) Those who are qualified as doctors, nurses, or genetic counselors.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Shibuya |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science Doctoral Course Student
Zip code
104-0044
Address
10-1 Akashi-chou, Chuo-ku, Tokyo, Japan
TEL
03-3543-6391
21dn011@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Shibuya |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science Doctoral Course Student
Zip code
1040044
Address
10-1 Akashi-chou, Chuo-ku, Tokyo, Japan
TEL
03-3543-6391
Homepage URL
21dn011@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Yuriko Shibuya
Funding Source
Organization
None
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
St. Luke's International University
Address
10-1 Akashi-chou, Chuo-ku, Tokyo, Japan
Tel
03-3543-6391
21dn011@slcn.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
| 2024 | Year | 10 | Month | 17 | 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
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063850
