NCT04832386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

March 22, 2021

Last Update Submit

April 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 28-questionnaire about the use of compression garments

    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.

    baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosed with breast cancer releated lymphedema

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

LymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Banu Dilek

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 5, 2021

Study Start

March 30, 2019

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

April 5, 2021

Record last verified: 2021-04

Locations