Clinical trial NCT04832386: COMPRESSION GARMENTS in BREAST CANCER-RELATED LYMPHEDEMA
Official title: COMPLIANCE TO COMPRESSION GARMENTS AND RELATED FACTORS AMONG PATIENTS With BREAST CANCER-RELATED LYMPHEDEMA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Lymphedema
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with breast cancer releated lymphedema

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age
* Diagnosed with breast cancer related lymphedema
* Having been prescribed compression garments

Exclusion Criteria:

* cognitive and / or psychiatric illness
* refusal to participate in the study

Primary outcomes:
measure: 28-questionnaire about the use of compression garments
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Banu Dilek
role: STUDY_DIRECTOR
References:
citation: Erdinc Gunduz N, Sahin E, Dilek B, Ellidokuz H, Akalin E. Adherence to Compression Garment Wear and Associated Factors Among Patients with Breast Cancer-Related Lymphedema: A Pilot Study from a Turkish Tertiary Center. Lymphat Res Biol. 2022 Dec;20(6):665-670. doi: 10.1089/lrb.2021.0091. Epub 2022 Mar 3.