UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046942 |
|---|---|
| Receipt number | R000053556 |
| Scientific Title | Effects of a decision aid for women with BRCA pathogenic variant considering cancer risk management strategies:A Mixed-Methods Study |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2026/08/23 10:04:42 |
* 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
Effects of a decision aid for women with BRCA pathogenic variant considering cancer risk management strategies:A Mixed-Methods Study
Acronym
Effects of a decision aid for women with BRCA pathogenic variant considering cancer risk management strategies
Scientific Title
Effects of a decision aid for women with BRCA pathogenic variant considering cancer risk management strategies:A Mixed-Methods Study
Scientific Title:Acronym
Effects of a decision aid for women with BRCA pathogenic variant considering cancer risk management strategies
Region
| Japan |
Condition
Condition
Hereditary breast and ovarian cancer
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a decision aid for women with BRCA pathogenic variant considering cancer risk management strategies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decision conflict scale
Preintervention and 4weeks after intervention 7days before and after
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
booklet style decision aid
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
20 years and older women with BRCA pathogenic variant
Key exclusion criteria
metastatic cancer patients
unable to understand Japanese
The physicians in charge judge it difficult for their patients to participate in the program
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Okawa |
Organization
St Luke's International Hospital
Division name
Nursing Department
Zip code
104-8560
Address
Akashi-cho Chuo-ku Tokyo
TEL
03-3541-5151
onmegu@luke.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Okawa |
Organization
St' Lukes International Hospital
Division name
Nursing Department
Zip code
104-8560
Address
Akashi-cho Chuo-ku Tokyo
TEL
03-3541-5151
Homepage URL
onmegu@luke.ac.jp
Sponsor or person
Institute
St Lukes International Hospital
Institute
Department
Personal name
Funding Source
Organization
applying
Organization
Division
Category of Funding Organization
Japanese Governmental office
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, Clinical Trial Office
Address
Akashi-cho, Chuo-ku, Tokyo
Tel
03-3541-5151
kenkyukikaku@luke.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
| 2022 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40766983/
Number of participants that the trial has enrolled
25
Results
All 25 participants completed the pre- and posttests. There was a significant reduction in the decisional conflict scale and a significant increase in the knowledge score. Significant improvements were identified in the decisional conflict scale score (g = 0.60, p = .002) and knowledge score (g = -1.44, p < .001). Four weeks post-intervention, 96% of the participants had made a decision regarding the management options for breast or ovarian care.
Results date posted
| 2025 | Year | 08 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese Women aged 20 years or older with a pathogenic BRCA1 or BRCA2 variant
Participant flow
Women who had been informed by their physician that they carried a pathogenic BRCA1 or BRCA2 variant were invited to participate in the study. After providing informed consent, participants completed a baseline survey and received the intervention materials. A follow-up survey was conducted one month later. Participants who additionally consented to an individual interview underwent an interview six months after the intervention.
Adverse events
None
Outcome measures
Primary Outcome
Change in decisional conflict, measured using the Decisional Conflict Scale (DCS)
Secondary Outcomes
Knowledge
Decision-making status
Decision choice
Level of engagement with the decision aid
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053556
