Presentation of First Time Attenders at Lymphedema Clinics

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema; Breast Neoplasm

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2006
      • University of Sydney, Faculty of Health Sciences
• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Two hundred women who have previously been treated for unilateral breast cancer and are referred for the first time to a lymphedema clinic. These patients presenting for the first time with breast cancer-related lymphedema will be asked to have an immediate objective assessment of their lymphedema and to administer additional questionnaires and clinical tests.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with breast cancer-related lymphedema; Individuals with upper limb lymphedema developed after breast cancer treatment
Healthy control subjects; Healthy individuals without breast cancer-related lymphoedema.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: University of Sydney
• Investigators: Principal Investigator: An De Groef, PhD, Universitaire Ziekenhuizen KU Leuven; Principal Investigator: Elizabeth Dylke, PhD, University of Sydney, Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: S59883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No