Presentation of First Time Attenders at Lymphedema Clinics

Study Overview
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Brief Summary
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The first aim of this research project is to identify what factors motivate patients to seek assessment for early lymphedema and further, to gain insight into the signs and symptoms of developing lymphedema and the concurrent physical measurements. The second aim is to identify other sensory signs and symptoms and changes in body perception which may be perceived by the patient as reflective of lymphedema, and to identify to which degree they contribute to the patients' motivation to seek referral to lymphedema clinics.

Detailed Description
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One of the most challenging morbidities after breast cancer treatment is lymphedema. Approximately 20% of women treated for breast cancer with axillary lymph node dissection will be diagnosed with lymphedema. Pre- and post-operatively, women are informed about changes suggestive of lymphedema and guided about seeking further assessment. The investigators presume that if symptoms occur, patients will seek assessment. However, it is unknown whether this is true or if those prospectively monitored present earlier for treatment, or whether other factors specifically drive patients to seek further assessment. Understanding the early experience and presentation of secondary lymphedema will improve patient education and detection programs.

Official Title
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Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study

Conditions
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Lymphedema, Breast Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women after breast cancer (> 18 years) with unilateral axillary lymph node dissection or sentinel node biopsy; mastectomy (with or without autologous reconstruction) or wide excision of the tumor able to give consent to participate in the research Exclusion Criteria: patients under the age of 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with breast cancer-related lymphedema<br>Individuals with upper limb lymphedema developed after breast cancer treatment | |
| Healthy control subjects<br>Healthy individuals without breast cancer-related lymphoedema. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracellular fluid in the arm | Bioimpedance spectroscopy (BIS) is a measurement tool used to determine the volume of extracellular fluid, of which lymph fluid is a component. | immediately after inclusion in the study | 
| Arm volume | Arm circumference measures are commonly used to diagnose and monitor lymphedema. | immediately after inclusion in the study | 
| Pitting | The pitting tests examines the responsiveness of tissue to pressure and can be used to help determine the stage of lymphedema. | immediately after inclusion in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported signs and symptoms of lymphedema | Norman questionnaire for early detection of lymphedema will be used; this validated questionnaire will allow us to determine the location and severity of the symptoms that the patients have experienced over the past three months as well as how much distress it has caused. | immediately after inclusion in the study | 
| Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema | Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): The Lymph-ICF is a reliable and valid questionnaire to assess impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema. | immediately after inclusion in the study | 
| Global Health Status/Quality of Life Score | Health-related quality of life assessed with the generic QLQ-C30 and the disease-specific QLQ-BR23 questionnaire | immediately after inclusion in the study | 
| Body perception | The BATH CRPS body perception disturbances scale: to assess body perception disturbances in breast cancer patients. | immediately after inclusion in the study | 
| Pain intensity assessed with the Numeric Rating Scale | Numeric Rating Scale for maximal pain intensity during the past week. | immediately after inclusion in the study | 
| Prevalence of neuropathic pain | Measured with the Douleur Neuropathique en 4 questions (DN4) | immediately after inclusion in the study | 
| Tactile acuity (Two-point discrimination) | To assess body perception two-point discrimination will be assessed at both arms, the breasts and lateral trunk side. | immediately after inclusion in the study | 
| Mechanical detection and pain threshold | The lowest mechanical forces, applied to the skin using nylon monofilaments that the subject can 1) detect and 2) is perceived as painful) are tested at the upper limb and upper body region. | immediately after inclusion in the study | 
| Temporal summation | Detection of perceived temporal summation at the upper limb and upper body region tested using repeated 26g nylon monofilament stimulation. | immediately after inclusion in the study |