UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063573 |
|---|---|
| Receipt number | R000072751 |
| Scientific Title | Feasibility Study of an Upper Limb Rehabilitation Program Using a Shoulder Rehabilitation Support App for Patients After Breast Cancer Surgery |
| Date of disclosure of the study information | 2026/11/09 |
| Last modified on | 2026/11/09 20:09:29 |
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Basic information
Public title
Feasibility Study of an Upper Limb Rehabilitation Program Using a Shoulder Rehabilitation Support App for Patients After Breast Cancer Surgery
Acronym
BC-ULR Feasibility Study
Scientific Title
Feasibility Study of an Upper Limb Rehabilitation Program Using a Shoulder Rehabilitation Support App for Patients After Breast Cancer Surgery
Scientific Title:Acronym
BC-ULR Feasibility Study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate the feasibility of an upper limb rehabilitation program using a shoulder rehabilitation support app in patients after breast cancer surgery. Feasibility will be assessed primarily by the proportion of patients achieving a predefined level of adherence to self-directed exercises, based on exercise completion records in the app. Secondary outcomes, including shoulder range of motion, upper limb function, pain, quality of life (QOL), activities of daily living (ADL), and safety, will also be explored.
Basic objectives2
Others
Basic objectives -Others
Feasibility assessment of an app-based upper limb rehabilitation program for patients after breast cancer surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients achieving a predefined level of adherence to the prescribed app-based self-directed exercise program
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients after breast cancer surgery will receive an upper limb rehabilitation program using a shoulder rehabilitation support app. The app provides exercise videos, functions for recording pain and other patient-reported information, and a function for recording exercise completion. Participants will perform self-directed exercises using the videos and record completion by pressing a completion button in the app. During outpatient visits, therapists will assess shoulder range of motion, pain, and other relevant clinical findings and adjust the exercise program according to each patient's condition. The intervention period will be approximately 8 weeks after surgery.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients aged 18 years or older at the time of obtaining informed consent.
2. Patients with breast cancer who are scheduled to undergo or have undergone breast-conserving surgery or total mastectomy with axillary lymph node dissection at the National Cancer Center Hospital East, excluding those undergoing immediate breast reconstruction.
3. Patients who have experience using a smartphone or who can receive assistance from family members in using a smartphone.
4. Patients who have received sufficient information about the study and have voluntarily provided written informed consent to participate.
5. Patients who are able to read and write Japanese.
Key exclusion criteria
1. Patients with a history of fracture, trauma, or surgery involving the shoulder joint on the operated side.
2. Patients who develop postoperative wound dehiscence or surgical site infection.
3. Patients who have difficulty using the app due to severe dementia or other cognitive impairments.
4. Patients deemed unsuitable for participation in the study by the principal investigator for any other reason.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | motoki |
| Middle name | meta |
| Last name | tanaka |
Organization
National Cancer Center Hospital East
Division name
Department of Rehabilitation Medicine
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL
0471331111
mottanak@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | motoki |
| Middle name | |
| Last name | tanaka |
Organization
National Cancer Center Hospital East
Division name
Department of Rehabilitation Medicine
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL
0471331111
Homepage URL
mottanak@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
Funding Source
Organization
Logos&Pathos Consulting
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
National Cancer Center Japan
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
Tel
0471331111
irst@ncc.go.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
| 2026 | Year | 11 | Month | 09 | 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
| 2026 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 11 | Month | 09 | Day |
Last modified on
| 2026 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072751
