Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04832386 |
| Other study ID # |
DokuzEU.Com.Garments |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 30, 2019 |
| Est. completion date |
August 29, 2019 |
Study information
| Verified date |
April 2021 |
| Source |
Dokuz Eylul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Breast cancer is the most common cancer in women. It is an important health problem that has
been increasingly encountered in recent years. With the advances in treatment, the survival
time after breast cancer is prolonged, and as a result, many women face certain diseases
during this period. One of these diseases, breast cancer-related lymphedema, is characterized
by abnormal accumulation of protein-rich fluid in the interstitial tissue, which can occur at
any time after breast cancer surgery or radiotherapy and is a major cause of morbidity. The
aims of the treatment of lymphedema are to reduce edema, prevent the increase of edema,
prevent infections, protect skin integrity, range of motion and limb functions. Complete
Decongestive Therapy (CDT) is recommended by the International Society of Lymphology (ISL) as
the international contemporary standard treatment for BCRL(breast cancer related lymphedema)
treatment. CDT is a treatment method that includes manual lymph drainage (MLD), multilayer
bandaging (Multilayer, short-stretch compression bandaging), exercise, skin care and
compression garment. Compression garments, which are the most important component of the
second phase of CDT, reduce the interstitial pressure of the extremity with the pressure they
apply, and reduce capillary filtration and lymph production. Regular use of compression
garments is very important during the treatment process. It is recommended that compression
garments be worn during all waking hours. The success of compression garments is closely
related to the patient's compliance with the treatment. Patients with lymphedema may need to
wear compression garments for life. Wearing compression garments may have some difficulties
for patients and this may affect compliance and adherence to treatment. The aim of this study
is to investigate the compliance to compression garments and related factors among patients
with breast cancer-related lymphedema.
Description:
This study was planned as a cross-sectional study. Patients diagnosed with unilateral breast
cancer-related lymphedema and recommended compression garments will be included in the study
on a voluntary basis, after obtaining their written consent. Patients who have received a
standard treatment and an education about the use of compression garments from a single
center will be asked to answer our 28-question questionnaire about the use of compression
garments. The patients will be asked whether compression garments were recommended or not,
how long they have used compression garments, the type and model of the recommended
compression garment, whether they can buy the recommended compression garment, how often it
is changed, how long it is recommended to wear it during the day, whether it is used for the
recommended time, how long wore during the day, the reasons for using and not using the
garment. Compliance to compression garments and the factors affecting this will be
questioned. Patients who use their garments for the recommended time and manner and those who
do not will be compared in terms of these factors. Patients who used their garments for the
recommended time and manner will be considered as compliant.
