UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037187 |
|---|---|
| Receipt number | R000041459 |
| Scientific Title | Effects of the Combined Exercise and Game-based Cognitive Training on cancer therapy-related cognitive impairment in patients with breast cancer: Mixed-methods study in the United States and Japan. |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2022/09/02 10:15:20 |
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Basic information
Public title
Effects of the Combined Exercise and Game-based Cognitive Training on cancer therapy-related cognitive impairment in patients with breast cancer: Mixed-methods study in the United States and Japan.
Acronym
Effects of the Combined Exercise and Game-based Cognitive Training on cancer therapy-related cognitive impairment in patients with breast cancer: Mixed-methods study in the United States and Japan.
Scientific Title
Effects of the Combined Exercise and Game-based Cognitive Training on cancer therapy-related cognitive impairment in patients with breast cancer: Mixed-methods study in the United States and Japan.
Scientific Title:Acronym
Effects of the Combined Exercise and Game-based Cognitive Training on cancer therapy-related cognitive impairment in patients with breast cancer: Mixed-methods study in the United States and Japan.
Region
| Japan | North America |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of a Combined Exercise and Game-based Cognitive Training intervention on cancer therapy-related cognitive changes in patients with breast cancer using a mixed-methods study design in the United States and Japan.
Basic objectives2
Others
Basic objectives -Others
This study aims to compare the differences of the effects of the intervention between the two countries.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive Function: Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog), The Trail Making Test (TMT) Parts A and B; The time of data collection is baseline, 4 weeks and 12 weeks
Key secondary outcomes
Functional Assessment of Cancer Therapy-General version4 (FACT-G)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
| Device,equipment |
Interventions/Control_1
Intervention group: Combined Exercise and Game-based Cognitive Training
Frequency: Participants will be asked to complete the Combined Exercise and Game-based Cognitive Training exercise sessions three times every week. Study participant perform at least 3 training sessions a week.
Duration: four weeks
Interventions/Control_2
Contorol group: normal living
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) women diagnosed with stage I- III breast cancer
(2) >/=20 years old, </=75 years old
(3) within 6 months to 5 years after completion of chemotherapy; current adjuvant anti-estrogen therapy allowed regardless of other therapies received; current anti-HER-2 therapy allowed.
(4) reporting symptoms of cognitive changes
(5)a Mini-Mental State Examination (MMSE) score of =>24
(6) ECOG (Eastern Cooperative Oncology Group) Performance Status is 0 or 1
(7) understood the disease and treatment (8) able to read and speak English or Japanese
(9) permission of recording an interview data
(10) Consent to participate in the study with consent form
Key exclusion criteria
(1) recurrence
(2) Sequelae of treatment for breast cancer (eg: restricted movement of shoulders and arms, pain) and adverse events (eg: feeling tired, peripheral nerve injury)
(3) diagnosis of mental disorders
(4) history of heart disease, respiratory disease
(5) CNS disease, or orthopedic disease
(6) history of brain or CNS radiation
(7) no one to accompany when it is needed to be assited acompany
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Miyashita |
Organization
Hiroshima University
Division name
Gerontological and Oncology Nursing, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5385
mikamiya@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Miyashita |
Organization
Hiroshima University
Division name
Gerontological and Oncology Nursing, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5385
Homepage URL
mikamiya@hiroshima-u.ac.jp
Sponsor or person
Institute
Gerontological and Oncology Nursing, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumamoto University, University of Kansas, Parker Adventist Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-1947
iryo-seisaku@office.hiroshima-u.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
広島大学病院（広島市）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2019 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041459
