UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029114 |
|---|---|
| Receipt number | 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 17:44:40 |
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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
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
sagaria@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033291
