UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057778 |
|---|---|
| Receipt number | R000066031 |
| Scientific Title | Effects of Attention Bias Modification on Cognitive dysfunction in Breast Cancer Patients |
| Date of disclosure of the study information | 2025/05/05 |
| Last modified on | 2025/05/05 13:09:04 |
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Basic information
Public title
Effects of Attention Bias Modification on Cognitive Decline in Breast Cancer Patients
Acronym
Effect of ABM on cognitive decline in breast cancer patients
Scientific Title
Effects of Attention Bias Modification on Cognitive dysfunction in Breast Cancer Patients
Scientific Title:Acronym
Effects of Attention Bias Modification on Cognitive dysfunction in Breast Cancer Patients
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verification whether the Attention Bias Modification Method reduces anxiety symptoms and cognitive decline in breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FACT-Cog
Key secondary outcomes
TMT, HVLT-R, verbal fluency task, attention bias, HADS, CFS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
attention bias modification
Interventions/Control_2
Placebo
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
Female breast cancer patients undergoing preoperative and postoperative adjuvant chemotherapy
Key exclusion criteria
Patients with brain metastases
Patients with psychiatric disorders such as schizophrenia or depression
Patients with obvious cognitive decline due to dementia
Patients in extremely poor general condition
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Ikio |
Organization
Kumamoto health Science University
Division name
Faculty of Health Science, Department of Rehabilitation, Occupational Therapy
Zip code
8615598
Address
325, Izumi Machi, Kumamoto Shi Kita Ku, Kumamoto Ken
TEL
096-275-2167
ikio@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Ikio |
Organization
Kumamoto health Science University
Division name
Faculty of Health Science, Department of Rehabilitation, Occupational Therapy
Zip code
8615598
Address
325, Izumi Machi, Kumamoto Shi Kita Ku, Kumamoto Ken
TEL
096-275-2167
Homepage URL
ikio@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto health Science University
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion of Science
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
Japanese Red Cross Society Nagasaki Genbaku Hospital
Address
3-15, Mori Machi, Nagasaki Shi, Nagasaki ken
Tel
095-847-1511
y.ikoiko@gmail.com
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
| 2025 | Year | 05 | Month | 05 | 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
| 2025 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 05 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066031
