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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029114
Receipt No. R000033291
Scientific Title Effect of Occupation-Based Interventions for Hematopoietic Malignancy Patients during Chemotherapy
Date of disclosure of the study information 2017/09/30
Last modified on 2017/09/12

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Basic information
Public title Effect of Occupation-Based Interventions for Hematopoietic Malignancy Patients during Chemotherapy
Acronym Effect of Occupation-Based Interventions for Hematopoietic Malignancy Patients during Chemotherapy
Scientific Title Effect of Occupation-Based Interventions for Hematopoietic Malignancy Patients during Chemotherapy
Scientific Title:Acronym Effect of Occupation-Based Interventions for Hematopoietic Malignancy Patients during Chemotherapy
Region
Japan

Condition
Condition Hematopoietic Malignancy Patients
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aimed to validate the efficacy of occupation-based interventions, in comparison with impairment-based interventions, designed using the Aid for Decision-making in Occupation Choice (ADOC) in patients with hematopoietic malignancies undergoing chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Assessment of Cancer Therapy General
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 For the experimental group, we set goals using the Aid for Decision-making in Occupation Choice(ADOC) and conducted an OBI. During their hospital stay, patients practiced the goals listed within medical facilities to the best of their ability (such as washing or cleaning tasks).
Interventions/Control_2 The control group underwent an Impairment-based interventions focusing on dysfunction. The participants performed strength training and aerobic exercise at a relatively high intensity (modified Borg scale score of <4). During home care, the participants were required to record their attempts of the activity set as their goal.
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
40 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Eligibility criteria included patients with hematopoietic tumors prescribed occupational therapy.
Key exclusion criteria exclusion criteria included a performance status of grade >2, mmse score <24 points, age <40 years, uncontrollable pain <3, therapy sessions and lack of consent to participate.

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Sagari
Organization Shinshu University
Division name Division of Occupational Therapy School of Health Science
Zip code
Address Asahi Matsumoto Nagano 3908621 Japan
TEL 0263-37-2404
Email sagaria@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Sagari
Organization Shinshu University
Division name Division of Occupational Therapy School of Health Science
Zip code
Address Asahi Matsumoto Nagano 3908621 Japan
TEL 0263-37-2404
Homepage URL
Email sagaria@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University
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
Address
Tel
Email

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
2017 Year 09 Month 30 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 Completed
Date of protocol fixation
2014 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 12 Day
Last modified on
2017 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033291

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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