UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055357 |
|---|---|
| Receipt number | R000058376 |
| Scientific Title | Effectiveness of an Online Self-Care Educational Program for Breast Cancer-Related Lymphedema: A Randomized Pilot Study |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/02/27 10:11:10 |
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Basic information
Public title
Effectiveness of an Online Self-Care Educational Program for Breast Cancer-Related Lymphedema: A Randomized Pilot Study
Acronym
Effectiveness of an Online Self-Care Educational Program for Breast Cancer-Related Lymphedema: A Randomized Pilot Study
Scientific Title
Effectiveness of an Online Self-Care Educational Program for Breast Cancer-Related Lymphedema: A Randomized Pilot Study
Scientific Title:Acronym
Effectiveness of an Online Self-Care Educational Program for Breast Cancer-Related Lymphedema: A Randomized Pilot Study
Region
| Japan |
Condition
Condition
Breast Cancer-Related Lymphedema
Classification by specialty
| Breast surgery | Rehabilitation medicine | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a six-month online exercise program on symptoms of breast cancer-related lymphedema.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effects of a six-month online exercise program on health-related quality of life (QOL) and self-care adherence in patients with breast cancer-related lymphedema.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Percent change in total breast cancer-related lymphedema symptom score
Key secondary outcomes
Health related Quality of life
Self-care adherence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group will be directed to a dedicated website for the intervention. On this website, they will engage in a six-month program to learn and practice exercises as well as standard BCRL self-care routines.
Exercises are to be completed twice a day at times chosen by the participants.
Daily activities such as measuring weight (once a day), skin care (three times a day), exercise, and applying compression therapy as needed will be recorded on a self-care check sheet.
Once a month, participants will share and discuss their lymphedema and self-care progress with other members of their group during a small-group online salon.
Interventions/Control_2
Participants in the control group will be directed to a website designated for the control group.
On this website, they will learn and practice standard BCRL self-care for six months.
Daily activities such as measuring weight (once a day), skin care (three times a day), exercise, and applying compression therapy as needed will be recorded on a self-care check sheet.
Once a month, participants will share and discuss their lymphedema and self-care progress with other members of their group during a small-group online salon.
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
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
Aged 18 years or older at the time of consent.
Have undergone surgery for breast cancer treatment.
Experiencing lymphedema symptoms (swelling in the upper body on the side of the surgery) for at least three months after breast cancer treatment.
Able to access the study website daily.
Able to attend an online salon once a month.
Key exclusion criteria
Has recurrent breast cancer or any other type of cancer.
Has received radiation or chemotherapy within the past six months, or plans to receive such treatments during the study period.
Has an infection, inflammation, or deep vein thrombosis in the arm on the side of the surgery.
Is unable to complete online questionnaires.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Arinaga |
Organization
Fukushima medical university
Division name
Faculty of nursing
Zip code
960-1295
Address
1Hikariga-oka, Fukushima City 960-1295, JAPAN
TEL
0245471111
arinaga@aimedicalri.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Arinaga |
Organization
Fukushima medical university
Division name
Faculty of nursing
Zip code
960-1295
Address
1Hikariga-oka, Fukushima City 960-1295, JAPAN
TEL
0245471111
Homepage URL
https://project-gembcrl.com/
arinaga@aimedicalri.com
Sponsor or person
Institute
Fukushima medical university
Institute
Department
Personal name
Yoko Arinaga
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Teikyou University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima medical university
Address
1Hikariga-oka, Fukushima City 960-1295, JAPAN
Tel
0245471111
rs@fmu.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 | 09 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | 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
| 2024 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058376
