Presentation of First Time Attenders at Lymphedema Clinics

NCT03687749 | Completed

• 1 other identifier: S59883
• Study Type: observational
• Target: 46
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Lymphedema; Breast Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Self-reported signs and symptoms of lymphedema

  immediately after inclusion in the study

• 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

  immediately after inclusion in the study

• Body perception

  immediately after inclusion in the study

• Pain intensity assessed with the Numeric Rating Scale

  immediately after inclusion in the study

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• patients under the age of 18 years

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University of Sydney: collaborator

Study Sites (2)

University of Sydney, Faculty of Health Sciences

Sydney, New South Wales, 2006, Australia

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• An De Groef, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Elizabeth Dylke, PhD

  University of Sydney, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: September 27, 2018
• Study Start: February 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: December 31, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BE (1)