Lymphedema of Upper Arm
Conditions
Keywords
breast cancer related lymphedema, lymphedema, outcome measurement, responsiveness
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.
Interventions
Complex decongestive therapy-phase 1 program consist of 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.
Sponsors
Marmara University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Patients with breast cancer related lymphedema who will undergo complex decongestive phase 1
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limb volume measurement | before treatment (T0) | Limb volume will be calculated based on truncated cone method from circumference measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymphedema Quality of Life Questionnaire-Arm | after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1) | The LYMQOL-Arm has been developed to assess the impact of lymphedema of the arms on the QoL of the patients. It consists of four domains with 28 items. These domains are symptoms, appearance, function, and mood. The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QoL. |
| Lymphedema Life Impact Scale (LLIS) | before treatment (T0) | The LLIS is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema. |
| Patient Benefit Index-Lymphedema(PBI) | before treatment (T0) | The Patient Benefit Index (PBI) methodology allows for a more direct measurement of patient-relevant treatment.benefit. In the first part the Patient Needs Questionnaire (PNQ)patients rate the importance of a list of patient relevant treatment goals on a five-step scale from not at all to very. In the second part the Patient Benefit Questionnaire (PBQ) patients rate to what extent the treatment goals have been achieved on the same five-step scale. Alternatively, they can choose does not apply to me for each treatment goal in both questionnaires. Thus, the patient directly evaluates treatment benefit instead of rating her/his current HRQoL before and after treatment. A PBI weighted global score ranging from 0 (no benefit) to 4 (maximum benefit) is computed for each patient. The weighting algorithm8 ensures that the achievement of important treatment goals will have higher impact on the global score than the achievement of less important goals. |
| Lymphedema Quality of Life Questionnaire-Arm (LYMQOL) | before treatment (T0) | The LYMQOL-Arm has been developed to assess the impact of lymphedema of the arms on the QoL of the patients. It consists of four domains with 28 items. These domains are symptoms, appearance, function, and mood. The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QoL. |
| European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30) | before treatment (T0) | The EORTC QLQ-C30 questionnaire is a survey conducted to evaluate the quality of life in patients with breast cancer. It consists of 30 questions which assess symptoms that occurred in the previous two weeks. Responses are given on a Likert scale: 1 - not at all, 2 - a little, 3 - quite a bit, 4 - very much. The global health scale consists of two questions asking patients to classify their general health and quality of life in the previous week, by rating it from 1 to 7, in which 1 means poor and 7, excellent. The questionnaires are divided into three scales: global health scale (GHS), functional scale (FS) and symptom scale (SS). |
| Short Form 36 (SF-36) | before treatment (T0) | The Short Form 36 (SF-36) Health Survey measures overall health. It has eight sections: Physical functioning (10), role limitations due to physical health (4), role limitations due to emotional problems (3), energy/fatigue (4), emotional well-being (5), social functioning (2), pain (2), and general health (5). Each scale is transformed into a 0-100 scale on the assumption that each scale carries equal weight. The lower the score, the more disability. |
| Lymphoedema functioning, disability and health questionnaire(Lymph-ICF) | before treatment (T0) | The Lymph-ICF questionnaire is composed of 29 questions. Each question is answered using a visual analog scale (VAS) ranging from 0 to 100 mm. The anchors for the impairments in function (e.g. Does your arm hurt?) are not at all and very much, and those for the activity limitations and participation restrictions (e.g. Are you able to carry heavy weights?) are very well and not at all. The Lymph-ICF has 5 domains: physical function, mental function, household activities, mobility activities, and life and social activities. The total score of the Lymph-ICF is equal to the sum of the scores of the questions divided by the total number of answered questions. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEsra Nur Nur Türkmen, PT
Backup ContactGulseren Akyuz, Prof
Outcome results
None listed