Presentation of First Time Attenders at Lymphedema Clinics

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687749
• Other study ID #: S59883
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 31, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Lymphedema

Locations

Country	Name	City	State
Australia	University of Sydney, Faculty of Health Sciences	Sydney	New South Wales
Belgium	University Hospital Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	University of Sydney

Countries where clinical trial is conducted

Australia,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Arm volume	Arm circumference measures are commonly used to diagnose and monitor lymphedema.	immediately after inclusion in the study
Primary	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	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
Secondary	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
Secondary	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
Secondary	Body perception	The BATH CRPS body perception disturbances scale: to assess body perception disturbances in breast cancer patients.	immediately after inclusion in the study
Secondary	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
Secondary	Prevalence of neuropathic pain	Measured with the Douleur Neuropathique en 4 questions (DN4)	immediately after inclusion in the study
Secondary	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
Secondary	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
Secondary	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