UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060134 |
|---|---|
| Receipt number | R000068774 |
| Scientific Title | Effects of a Home-Based Exercise Digital Teaching Material and a Mobile App Walking Intervention for Post-Initial Treatment Breast Cancer Survivors: A Pilot Study |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/19 14:29:35 |
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Basic information
Public title
Effects of a Home-Based Exercise Digital Teaching Material and a Mobile App Walking Intervention for Post-Initial Treatment Breast Cancer Survivors
Acronym
HOMEWALK BCS Study
Scientific Title
Effects of a Home-Based Exercise Digital Teaching Material and a Mobile App Walking Intervention for Post-Initial Treatment Breast Cancer Survivors: A Pilot Study
Scientific Title:Acronym
HOMEWALK BCS Study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of delivering a walking intervention using digital teaching materials and a mobile application for individuals who have completed initial treatment for breast cancer, and to evaluate the acceptability, adherence, and preliminary effects of the intervention, with the goal of informing the design of a future randomized controlled trial.
Basic objectives2
Others
Basic objectives -Others
Psychosocial Effects of a Walking Intervention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body Composition Body Weight Quality of Life Physical Activity and Exercise Self-Efficacy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A single-group intervention will be conducted three times.
The first session will involve explaining and implementing the exercise program.
The second session will take place one month later, and the third session will be conducted three months after the first.
To assess whether participants are able to continue the home-based exercise program, data from the mobile application, as well as changes in body composition, body weight, resilience, quality of life (QOL), and self-efficacy will be measured.
During the second and third sessions, group discussions will be held to explore changes in motivation for continuing exercise and strategies participants have used to maintain their exercise habits.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1.Female breast cancer survivors who have completed initial treatments.
2.No restrictions on cancer stage.
3.Able to perform activities of daily living independently.
4.Within five years after completion of initial treatment.
5.Have not continuously engaged in vigorous physical activities. Such as running, aerobics, or swimming that induce sweating and shortness of breath for 30 minutes or more at least twice per week for the past year.
6.Regular users of a smartphone in daily life.
7.Have received medical clearance from a physician to participate in exercise.
8.Physically and mentally capable of understanding the study information sheet and responding to the study questionnaires.
Key exclusion criteria
1.If a participant, after providing written informed consent and enrolling in the study, expresses the intention to withdraw consent.
2.If the participant experiences health deterioration or cancer recurrence requiring medical treatment.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | MICHIKO |
| Middle name | |
| Last name | SUNAGA |
Organization
Takasaki University of Health and Welfare
Division name
Dept of Nursing Faculty of Health Care
Zip code
3700033
Address
27,NAKAORUI-MACHI TAKASAKI-SHI,GUNMA
TEL
0273521291
sunaga@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | MICHIKO |
| Middle name | |
| Last name | SUNAGA |
Organization
Takasaki University of Health and Welfare
Division name
Dept of Nursing Faculty of Health Care
Zip code
3700033
Address
27,NAKAORUI-MACHI TAKASAKI-SHI,GUNMA
TEL
0273521291
Homepage URL
sunaga@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
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
Takasaki University of Health and Welfare
Address
27,NAKAORUI-MACHI TAKASAKI-SHI,GUNMA
Tel
0273521291
sunaga@takasaki-u.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 | 12 | Month | 22 | 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
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 25 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068774
