COMPRESSION GARMENTS in BREAST CANCER-RELATED LYMPHEDEMA

NCT ID: NCT04832386

Last Updated: 2021-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-30

Study Completion Date

2019-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Lymphedema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Banu Dilek

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Banu Dilek

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35245100 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DokuzEU.Com.Garments

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.