Clinical trial NCT03687749: Presentation of First Time Attenders at Lymphedema Clinics
Official title: Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Breast Neoplasm
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2018-09-27
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Extracellular fluid in the arm
timeFrame: immediately after inclusion in the study
measure: Arm volume
timeFrame: immediately after inclusion in the study
measure: Pitting
timeFrame: immediately after inclusion in the study
Secondary outcomes:
measure: Self-reported signs and symptoms of lymphedema
timeFrame: immediately after inclusion in the study
measure: Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema
timeFrame: immediately after inclusion in the study
measure: Global Health Status/Quality of Life Score
timeFrame: immediately after inclusion in the study
measure: Body perception
timeFrame: immediately after inclusion in the study
measure: Pain intensity assessed with the Numeric Rating Scale
timeFrame: immediately after inclusion in the study
measure: Prevalence of neuropathic pain
timeFrame: immediately after inclusion in the study
measure: Tactile acuity (Two-point discrimination)
timeFrame: immediately after inclusion in the study
measure: Mechanical detection and pain threshold
timeFrame: immediately after inclusion in the study
measure: Temporal summation
timeFrame: immediately after inclusion in the study
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of Sydney, Faculty of Health Sciences
state: New South Wales
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: An De Groef, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney, Faculty of Health Sciences
name: Elizabeth Dylke, PhD
role: PRINCIPAL_INVESTIGATOR
References: