Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema

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

Detailed Description
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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.

Official Title
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Investigation and Comparison of Lymphedema Outcome Measurements Validated in Turkish for Assessment of Breast Cancer Related Lymphedema

Conditions
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Lymphedema of Upper Arm

Intervention / Treatment
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* Other: complex decongestive therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with breast cancer related lymphedema who will undergo complex decongestive phase 1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with post-mastectomy lymphedema<br>Patients with breast cancer related lymphedema who will undergo complex decongestive therapy | Other: complex decongestive therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb volume measurement | Limb volume will be calculated based on truncated cone method from circumference measurements | before treatment (T0) | 
| Limb volume measurement | Limb volume will be calculated based on truncated cone method from circumference measurements | after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphedema Quality of Life Questionnaire-Arm (LYMQOL) | 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. | before treatment (T0) | 
| Lymphedema Quality of Life Questionnaire-Arm | 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. | after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1) | 
| Lymphedema Life Impact Scale (LLIS) | The LLIS is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema. | before treatment (T0) | 
| Lymphedema Life Impact Scale (LLIS) | The LLIS is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema. | after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1) | 
| Patient Benefit Index-Lymphedema(PBI) | 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. | before treatment (T0) | 
| Patient Benefit Index-Lymphedema(PBI) | 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. | after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1) | 
| Lymphoedema functioning, disability and health questionnaire(Lymph-ICF) | 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. | before treatment (T0) | 
| Lymphoedema functioning, disability and health questionnaire(Lymph-ICF) | 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. | after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1) | 
| European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30) | 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). | before treatment (T0) | 
| European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30) | 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). | after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1) | 
| Short Form 36 (SF-36) | 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. | before treatment (T0) | 
| Short Form 36 (SF-36) | 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. | after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer related lymphedema, lymphedema, outcome measurement, responsiveness