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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043614
Receipt No. R000049799
Scientific Title Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Date of disclosure of the study information 2021/03/25
Last modified on 2021/03/15

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Basic information
Public title Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Acronym Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Scientific Title Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Scientific Title:Acronym Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Region
Japan

Condition
Condition Brain tumor
Classification by specialty
Neurosurgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether occupational therapy based on OBI for patients with brain tumors is effective in maintaining and improving the QOL of patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes As a primary outcome, QOL's The European Organization for Research and Treatment of Cancer QLQ-C30 will be evaluated before and during the final intervention.
Key secondary outcomes Secondary outcomes include the National Institutes of Health Stroke Scale, Brunnstrom stage, grip strength, and knee extension muscle strength. We will implement a walking speed of 10m as a walking ability. The Mini Mental State Examination will be conducted as a cognitive function. Functional independence measure and Barthel index are implemented as ADL ability. As a mental function, we will carry out the Hospital Anxiety and Depression Scale. The above evaluation will be performed before the intervention and at the time of the final intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Create a list of patients who will be hospitalized for brain tumor resection and undergo rehabilitation intervention from April 1, 2021 to January 31, 2022. Explain the study to patients who meet the eligibility criteria and obtain their consent. Initial evaluation is performed before surgery and intervention is started after surgery. In the occupation-based intervention implementation group, clear goals are set using work selection decision support software, and work-based interventions are implemented. The intervention is 60 minutes, two-thirds perform meaningful work interventions based on life history, and one-third perform functional exercises. The frequency of intervention is 5 times a week.
Interventions/Control_2 From January 1, 2020 to March 31, 2021, we will prepare a list of patients who will be hospitalized for the purpose of brain tumor resection and will undergo rehabilitation intervention. Explain the study to patients who meet the eligibility criteria and obtain their consent. Initial evaluation is performed before surgery and intervention is started after surgery. In the occupation-based intervention non-execution group, two-thirds practiced functions and one-third performed activities of daily living, without using goal setting tools such as work selection decision support software and Canadian Occupational Performance Measure. Instrumental Activities of Daily Living Practice. The frequency of intervention is 5 times a week.
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 Male and Female
Key inclusion criteria The selection criteria were cases in which consent was obtained for participation in this study, cases diagnosed as brain tumors, cases in which rehabilitation intervention was performed after brain tumor removal, cases over 20 years old, and cases with Mini Mental Stage Examination 24 points or more.
Key exclusion criteria Exclusion criteria include cases with a history of congenital disorders or diseases in the central nervous system, cases with a Mini Mental Stage Examination of 23 points or less, cases in which the consent of the patient was not obtained, and other cases in which the principal investigator is inappropriate as a subject. The case was judged to be.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Ito
Middle name
Last name Syun
Organization Shinshu University Hospital
Division name Rehabilitation department
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL 0263-37-2836
Email itosyun@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Ito
Middle name
Last name Syun
Organization Shinshu University Hospital
Division name Rehabilitation department
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL 0263-37-2836
Homepage URL
Email itosyun@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital
Institute
Department

Funding Source
Organization Japan Occupational Therapists Association
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 Shinshu University Hospital
Address 3-1-1 Asahi, Matsumoto City, Nagano Prefecture
Tel 0263-37-2836
Email itosyun@shinshu-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 信州大学医学部附属病院(長野県)

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 25 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
2021 Year 03 Month 31 Day
Date of IRB
2021 Year 02 Month 12 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 Year 01 Month 31 Day
Date of closure to data entry
2023 Year 01 Month 31 Day
Date trial data considered complete
2023 Year 01 Month 31 Day
Date analysis concluded
2023 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 03 Month 15 Day
Last modified on
2021 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049799

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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