Clinical trial NCT04138667: Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema
Official title: Investigation and Comparison of Lymphedema Outcome Measurements Validated in Turkish for Assessment of Breast Cancer Related Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema of Upper Arm
Keywords: breast cancer related lymphedema
lymphedema
outcome measurement
responsiveness
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with breast cancer related lymphedema who will undergo complex decongestive phase 1
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

-Patients with unilateral postmastectomy lymphedema with a International Society of Lymphology-ISL) stage 2 and 3

Exclusion Criteria:

* Bilateral lymphedema
* The patients who had known systemic edematogenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence
* Patients with contraindications for application of complex decongestive therapy (active cutaneous infection, deep vein thrombosis, cardiac edema, and peripheral artery disease)

Primary outcomes:
measure: Limb volume measurement
timeFrame: before treatment (T0)
measure: Limb volume measurement
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Secondary outcomes:
measure: Lymphedema Quality of Life Questionnaire-Arm (LYMQOL)
timeFrame: before treatment (T0)
measure: Lymphedema Quality of Life Questionnaire-Arm
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Lymphedema Life Impact Scale (LLIS)
timeFrame: before treatment (T0)
measure: Lymphedema Life Impact Scale (LLIS)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Patient Benefit Index-Lymphedema(PBI)
timeFrame: before treatment (T0)
measure: Patient Benefit Index-Lymphedema(PBI)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Lymphoedema functioning, disability and health questionnaire(Lymph-ICF)
timeFrame: before treatment (T0)
measure: Lymphoedema functioning, disability and health questionnaire(Lymph-ICF)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30)
timeFrame: before treatment (T0)
measure: European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Short Form 36 (SF-36)
timeFrame: before treatment (T0)
measure: Short Form 36 (SF-36)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: Gulseren Akyuz, Prof
role: STUDY_CHAIR
References:
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citation: Bakar Y, Tugral A, Ozdemir O, Duygu E, Uyeturk U. Translation and Validation of the Turkish Version of Lymphedema Quality of Life Tool (LYMQOL) in Patients with Breast Cancer Related Lymphedema. Eur J Breast Health. 2017 Jul 1;13(3):123-128. doi: 10.5152/ejbh.2017.3522. eCollection 2017 Jul.
citation: Kostanoglu A, Hosbay Z, Tarakci E. Lymphoedema functioning, disability and health questionnaire Turkish version: translation, cross-cultural adaptation and validation. J Phys Ther Sci. 2016 Jun;28(6):1728-32. doi: 10.1589/jpts.28.1728. Epub 2016 Jun 28.