UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056917 |
|---|---|
| Receipt number | R000064308 |
| Scientific Title | Examining the Impact of Online Light Exercise on Fatigue in Childhood Cancer Survivors Who Have Completed Inpatient Treatment: A Feasibility Study |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2026/02/04 09:13:09 |
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Basic information
Public title
Examining the Impact of Online Light Exercise on Fatigue in Childhood Cancer Survivors Who Have Completed Inpatient Treatment: A Feasibility Study
Acronym
Examining the Impact of Online Light Exercise on Fatigue in Childhood Cancer Survivors Who Have Completed Inpatient Treatment: A Feasibility Study
Scientific Title
Examining the Impact of Online Light Exercise on Fatigue in Childhood Cancer Survivors Who Have Completed Inpatient Treatment: A Feasibility Study
Scientific Title:Acronym
Examining the Impact of Online Light Exercise on Fatigue in Childhood Cancer Survivors Who Have Completed Inpatient Treatment: A Feasibility Study
Region
| Japan |
Condition
Condition
childhood cancer
Classification by specialty
| Pediatrics | Rehabilitation medicine | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of light exercise on fatigue in adolescent childhood cancer survivors who have completed inpatient treatment.
Evaluate the feasibility of using the online-based Light Exercise.
Basic objectives2
Others
Basic objectives -Others
Verification of Impact
feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue Scale after pediatric cancer treatment (before and 8 weeks after the Light Exercise intervention)
Key secondary outcomes
Feasibility
Self-Efficacy Scale
Children's Daytime Sleepiness Scale
Depression Severity Scale
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 light exercise 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
Diagnosed with malignancy (any type of cancer) between the ages of 0 and 15
Are being followed at a pediatric outpatient clinic (including those on maintenance therapy)
Consent of the patient and guardian must be obtained.
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
10
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Shiwaku |
Organization
Graduate School of Medicine, Tohoku University
Division name
Pediatric Nursing
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7921
med-chn-exercise-project@grp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masayo |
| Middle name | |
| Last name | Saito |
Organization
Akita University Graduate School of Medicine
Division name
Department of Nursing, Pediatric Nursing
Zip code
010-8543
Address
1-1-1 Hondo, Akita City, Akita Prefecture
TEL
018-884-6508
Homepage URL
med-chn-exercise-project@grp.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,Akita University Hospital, Nakadori General Hospital, Hirosaki University, Hirosaki University Hospital, Miyagi University, Tohoku University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
Tel
022-728-4105
ec-med@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
| 2025 | Year | 02 | Month | 20 | 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
6
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 03 | 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
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064308
