Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema

Status Recruiting

Clinical Trial Summary

The aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish.

Clinical Trial Description

Lymphedema is defined as the excessive and persistent accumulation of fluid, extracellular proteins, and fat in tissue spaces, caused by inefficiency of the lymphatic drainage system. It is a chronic, progressive condition. Several researchers have investigated the influence on health-related quality of life in upper limb lymphedema after breast cancer treatment using patient reported outcome instruments. Responsiveness of only one of the lymphedema assessment scale, ''Lymphedema Quality of Life Inventory'', has been investigated. Responsiveness of lymphedema assessment scales validated in Turkish has not been examined in detail, thereby limiting their use in clinical trials. Therefore, the aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish. Patients with breast cancer related lymphedema with International Society of Lymphology-ISL lymphedema stage 2,3 will be included in the study and will receive complex decongestive therapy phase I including meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist. Limb volume will be calculated based on truncated cone method from circumference measurements. Patients will complete Lymphedema Life Impact Scale (LLIS), Patient Benefit Index-Lymphedema(PBI), Lymphedema functioning, disability and health questionnaire(Lymph-ICF), European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer (EORTC-QLQ-30) and Short Form 36 (SF-36) before and after treatment. Changes in limb volumes will be compared in changes in scales after treatment. Responsiveness of the subscales will be will be determined by calculating the effect size (change in all patients), standardized mean response (effect size in a group with improvement), and Guyatt's Responsiveness Index. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04138667
Study type	Interventional
Source	Marmara University
Contact	Esra Nur Nur Türkmen, PT
Phone	+905545239830
Email	e.nur5313@hotmail.com
Status	Recruiting
Phase	N/A
Start date	October 19, 2019
Completion date	May 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03492476` - Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema	N/A
Completed	`NCT03676127` - Diagnostic Accuracy of Dermal Thickness in Lymphedema
Completed	`NCT04570722` - Ipsilateral Peripheral Intravenous Access Procedures (The iPIVAP Study)	N/A
Completed	`NCT06230913` - Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema.	N/A
Recruiting	`NCT03210311` - Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema	N/A
Not yet recruiting	`NCT04435639` - Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema	N/A
Active, not recruiting	`NCT02691624` - Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation
Not yet recruiting	`NCT04139291` - Ultrasonographic Evaluation of Changes After Complex Decongestive Therapy	N/A
Recruiting	`NCT04296929` - The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.	N/A
Recruiting	`NCT06144164` - A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer	Phase 3
Completed	`NCT05278871` - Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors	N/A
Not yet recruiting	`NCT06407791` - Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity	N/A
Recruiting	`NCT04908254` - A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema	N/A
Completed	`NCT04881604` - Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	N/A
Recruiting	`NCT05203835` - Trial of Acebilustat for the Treatment of Upper Arm Lymphedema	Phase 2
Recruiting	`NCT04934098` - Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema	N/A
Recruiting	`NCT04203069` - Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase	N/A
Withdrawn	`NCT04246034` - Microvascular Breast Reconstruction With Lymph Node Transfer	N/A
Completed	`NCT04213001` - Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema	N/A
Recruiting	`NCT04690439` - Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema	N/A