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The Validation of a program to promote adherence of compression therapy in elderly patients with lower limb lymphedema.: a randomized controlled trial

The Validation of a program to promote adherence of compression therapy in elderly patients with lower limb lymphedema.: a randomized controlled trial - The Validation of a program to promote adherence of compression therapy in elderly patients with lower limb lymphedema.: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052038
Enrollment
60
Registered
2023-08-29
Start date
2023-10-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with cancer diagnosed with lymphedema of the lower extremities after cancer treatment

Interventions

Patients who meet the eligibility criteria will be instructed on lymphedema self-care after baseline data are obtained, using the leaflet &quot
Cancer Treatment and Lymphedema: Therapy from Now on&quot
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 cir
self-care diary&quot
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 dress
self-care diary,&quot
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
Cancer Therapy and Lymphedema: Treatment from This&quot
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 typ
and asked to observe the edema and the skin on the edema side by themselves, as well as to check off

Sponsors

Kyoto university Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTomoko Izawa

Kyoto university hospital department of nursing

tizawa@kuhp.kyoto-u.ac.jp0757513744

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026