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Completed

NCT Number: NCT04832386

COMPRESSION GARMENTS in BREAST CANCER-RELATED LYMPHEDEMA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 28-questionnaire about the use of compression garments

    Time frame: baseline

    Patients will be asked to answer our 28-questionnaire about the use of compression garments. Patients who used their garments for the recommended time and manner will be considered as compliant.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

COMPLIANCE TO COMPRESSION GARMENTS AND RELATED FACTORS AMONG PATIENTS With BREAST CANCER-RELATED LYMPHEDEMA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2021
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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