UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052986 |
|---|---|
| Receipt number | R000060437 |
| Scientific Title | Effects of Yoga on Improving Fatigue and Mental Health in Childhood Cancer Survivors: A Feasibility Study |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/01/31 10:33:41 |
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Basic information
Public title
Effects of Yoga on Improving Fatigue and Mental Health in Childhood Cancer Survivors: A Feasibility Study
Acronym
Effects of Yoga on Improving Fatigue and Mental Health in Childhood Cancer Survivors: A Feasibility Study
Scientific Title
Effects of Yoga on Improving Fatigue and Mental Health in Childhood Cancer Survivors: A Feasibility Study
Scientific Title:Acronym
Effects of Yoga on Improving Fatigue and Mental Health in Childhood Cancer Survivors: A Feasibility Study
Region
| Japan |
Condition
Condition
Pediatric cancer
Classification by specialty
| Pediatrics | Rehabilitation medicine | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the feasibility of a yoga intervention for childhood cancer survivors.
Determining the Effects of Yoga Intervention on Fatigue and Its Association with Mental Health in Childhood Cancer Survivors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer related Fatigue Scale off therapy fatigue
Before yoga intervention, 8 weeks after intervention, and 16 weeks after intervention.
Key secondary outcomes
General Self Efficacy Scale
The pediatric daytime sleepiness scale
PHQ-9 modified for Adolescents
Before yoga intervention, 8 weeks after intervention, and 16 weeks after intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
8 weeks of online yoga intervention.
Interventions/Control_2
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
| 13 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Childhood cancer survivors between the ages of 13 and 18 years
0-15 years old and diagnosed with a malignant tumor (any type of cancer)
Those who are being followed up at the pediatric outpatient clinic (including those on maintenance therapy)
Consent must be obtained from the patient and his/her guardian
Must be informed of childhood cancer
Key exclusion criteria
Those who cannot read or write Japanese
Those who have relapsed or are undergoing treatment for a second cancer
Those who have been disqualified from participating in the survey by the investigator
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | none |
| Last name | Shiwaku |
Organization
Tohoku University graduate School of Medicine
Division name
Department of Child Health Nursing
Zip code
980-0872
Address
2-1 Seiryocho, Aobaku, Sendai CitySendai, Miyagi
TEL
022-717-7921
hsiwaku@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | masayo |
| Middle name | none |
| Last name | saito |
Organization
School of health sciences Akita University
Division name
Course of nursing
Zip code
010-8543
Address
1-1-1 Hondo Akita City Akita
TEL
018-884-6521
Homepage URL
yoga-project@chn.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
AKITA UNIVERSITY NAKADORI General Hospital HIROSAKI UNIVERSITY MIYAGI UNIVERSITY
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Ethics Review Committee
Address
2-1 Seiryocho, Aobaku, Sendai City, Miyagi Prefecture
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060437
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| Registered date | File name |
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| Registered date | File name |
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