UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057319 |
|---|---|
| Receipt number | R000065513 |
| Scientific Title | Web-based Exercise Program for Childhood Cancer Survivors in Working Stage; Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/10/18 17:09:28 |
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Basic information
Public title
Web-based Program to increase Exercise Momentum for Childhood Cancer Survivors in Working Stage
Acronym
Web Exercise Test for CCS
Scientific Title
Web-based Exercise Program for Childhood Cancer Survivors in Working Stage;
Pilot Randomized Controlled Trial
Scientific Title:Acronym
Web Exercise Test for CCS
Region
| Japan |
Condition
Condition
leukemia and malignant lymphoma
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility of a 12-week exercise web program for survivors of childhood cancer. This program will support survivors of childhood cancer in increasing the duration and continuity of moderate-to-vigorous intensity exercise by providing information on exercise that is appropriate for their physical fitness and late complications.
Basic objectives2
Others
Basic objectives -Others
feasibility study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Step count on pedometer, weight, SF-8 Japanese version, exercise self-efficacy;
Measured at before the intervention and after 12 weeks of the intervention
Key secondary outcomes
Step count on pedometer, weight, SF-8 Japanese version, exercise self-efficacy;
Measured at before the intervention and after 12 weeks of the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Interventions
(1)Data input: Before and after the intervention, the type of exercise, weekly exercise volume, number of steps, and sleep time are measured using a smartwatch for one week, and input the data. Basic attributes, information on diseases, SF8, exercise self-efficacy, and the stage of change in exercise behavior are answered in questionnaires.
(2)Self-management: Enter their weight and the time spent doing moderate- and high-intensity exercise using the METs button each week. The data is displayed as a line graph.
(3)Health information: Watch a 10-minute video about pediatric cancer, guidelines, exercise, nutrition, sleep, and breathing techniques for stress reduction.
(4)Exercise program: Referring to the St. Jude Lifetime Cohort Study (2017), late complications are displayed in order of risk for each disease. Furthermore, referring to the American College of Sports Medicine's exercise prescription guidelines (2018), exercise videos of several to ten minutes in length are presented that are linked to late complications, and these are viewed at least once a week to lead to actual exercise. Exercise intensity is divided into light to high intensity of 5 levels, and before starting, exercise intensity is proposed according to exercise habits, and after 6 weeks, it is recommended to increase the level.
(5)Follow-up: During the intervention period, survivors can participate in online meetings three times at their discretion, to check their exercise movements with a sports instructor and exchange opinions with other participants.
Interventions/Control_2
Control
During the 12-week intervention period, the following will be done.
(1)Data input: Input questionnaires with the same items as the intervention group before and after the intervention via the web. Input data measured by the smartwatch.
(2)View the PDF version of the brochure on the web.
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The following criteria must all be met.
(1)Survivors who have experienced cancer who have been diagnosed with leukemia or malignant lymphoma and have been free of cancer for at least 5 years since the end of cancer treatment
(2)Survivors who were under 15 years old when they were diagnosed with cancer
(3)Survivors who are between 18 and 39 years old at the time of obtaining consent
(4)Survivors who have given written consent to participate in this study
Key exclusion criteria
Persons who fall under any of the following will not be included in this study.
(1)Survivors who have exercise restrictions from a doctor
(2)Those with dizziness, unsteadiness, or balance problems
(3)Survivors deemed unsuitable by the principal investigator
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Fukui |
Organization
Teikyo University of Science
Division name
Faculty of Medical Sciences Department of Nursing
Zip code
120-0045
Address
2-2-1 Senju Sakuragi, Adachi Ward, Tokyo
TEL
090-9200-6713
iku-fukui@ntu.ac.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Fukui |
Organization
Teikyo University of Science
Division name
Faculty of Medical Sciences Department of Nursing
Zip code
120-0045
Address
2-2-1 Senju Sakuragi, Adachi Ward, Tokyo
TEL
090-9200-6713
Homepage URL
iku-fukui@ntu.ac.jp
Sponsor or person
Institute
Teikyo University of Science
Institute
Department
Personal name
Ikuko Fukui
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
St. Luke's International Hospital
Name of secondary funder(s)
Teikyo University of Science
IRB Contact (For public release)
Organization
Teikyo University of Science
Address
2-2-1 Senju Sakuragi, Adachi Ward, Tokyo
Tel
090-9200-6713
iku-fukui@ntu.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
聖路加国際病院（東京都）、埼玉県立がんセンター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065513
