UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052038 |
|---|---|
| Receipt number | R000058222 |
| Scientific Title | The Validation of a program to promote adherence of compression therapy in elderly patients with lower limb lymphedema.: a randomized controlled trial |
| Date of disclosure of the study information | 2023/08/29 |
| Last modified on | 2024/08/29 13:33:03 |
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Basic information
Public title
The Validation of a program to promote adherence of compression therapy in elderly patients with lower limb lymphedema.: a randomized controlled trial
Acronym
The Validation of a program to promote adherence of compression therapy in elderly patients with lower limb lymphedema.: a randomized controlled trial
Scientific Title
The Validation of a program to promote adherence of compression therapy in elderly patients with lower limb lymphedema.: a randomized controlled trial
Scientific Title:Acronym
The Validation of a program to promote adherence of compression therapy in elderly patients with lower limb lymphedema.: a randomized controlled trial
Region
| Japan |
Condition
Condition
Patients with cancer diagnosed with lymphedema of the lower extremities after cancer treatment
Classification by specialty
| Obstetrics and Gynecology | Plastic surgery | Rehabilitation medicine |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized, concurrent, controlled feasibility study will be conducted to test the feasibility of a "program to promote adherence to compression therapy" in cancer patients diagnosed with lower extremity lymphedema who are 65 years of age or older to determine if patients will continue to receive compression therapy compared to a group of patients receiving standard care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Calculate the continuation rate of compression therapy at baseline, 1 month after allocation, and 3 months after allocation from the "self-care diary". The continuation rate is calculated from the denominator of the self-care diary (30 days after 1 month and 90 days after 3 months) to the number of days performed (numerator). If the self-care diary cannot be written (forgotten), it is considered "missing" and the number of days is considered not performed.
Key secondary outcomes
1) Change in quality of life measures at baseline, 1 month after allocation, and 3 months after allocation
2) Percentage decrease in edema volume at baseline, 1 month after allocation, and 3 months after allocation
3) Skin condition on the affected side (CTCAEver 5.0) at baseline, 1 month after allocation, and 3 months after allocation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients who meet the eligibility criteria will be instructed on lymphedema self-care after baseline data are obtained, using the leaflet "Cancer Treatment and Lymphedema: Therapy from Now on" published by Cancer Information of the National Cancer Center.
Subjects who are in the intervention group will select and wear one-leg type stockings (5-10 mmhg) based on the measurement of the circumference of edema. The subjects will also be asked to observe the edema and the skin on the edema side by themselves using a "self-care diary" and to check off the days when compression therapy is performed. Explain the need for continuity of compression therapy to the family members living with the subject and ask for their support in dressing and undressing the subject. If the subject is unable to keep a "self-care diary," family members should perform the checks instead. Observation of edema and skin should also be done by the family together. The researcher will call the subject once a week to check on the continuity of the compression therapy, to promote wearing it and to explain what to do in case of difficulties.
Interventions/Control_2
For the comparison group, the co-investigator will provide instruction on lymphedema self-care to patients who meet the eligibility criteria, after baseline data are obtained, using the leaflet "Cancer Therapy and Lymphedema: Treatment from This" published by Cancer Information, National Cancer Center. Subjects who are in the comparison group will be selected from the measurement of the circumference of edema, and explained to wear one-leg type stockings. In addition, the patients will be handed a "self-care diary" and asked to observe the edema and the skin on the edema side by themselves, as well as to check off the days when compression therapy is performed. The researcher will provide standard lymphedema care within the scope of usual medical practice.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients 65 years of age or older
2.Patients with a diagnosis of lymphedema of the lower limbs according to the diagnostic criteria of the International Lymphedema Society
Key exclusion criteria
1. Those with DVT or venous edema in the lower extremities
2. Those who have edema all over the body due to cardiac or renal failure
3. Those who cannot obtain cooperation from their family members living with them.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Izawa |
Organization
kyoto university hospital
Division name
department of nursing
Zip code
6068507
Address
53 kawahara-cho shougoin sakyo-ku, kyoto, Japan
TEL
0757513744
tizawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Izawa |
Organization
Kyoto university hospital
Division name
department of nursing
Zip code
606-8507
Address
53kawahara-cho, shogoin, sakyo-ku, kyoto
TEL
0757513744
Homepage URL
tizawa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university Hospital
Institute
Department
Personal name
IzawaTomoko
Funding Source
Organization
Kyoto university Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university graduate school and faculty of medicine, ethics committee
Address
Yoshida-konoe-cho, sakyo-ku, kyoto 606-8501
Tel
075-753-4642
ethcom@kuhp.kyoto-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
| 2023 | Year | 08 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 05 | 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
Research has been initiated and so far six people have entered the study and five have completed it. The study will continue to be implemented.
Management information
Registered date
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058222
