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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03687749
Registration number
NCT03687749
Ethics application status
Date submitted
10/07/2018
Date registered
27/09/2018
Date last updated
30/04/2021
Titles & IDs
Public title
Presentation of First Time Attenders at Lymphedema Clinics
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Scientific title
Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study
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Secondary ID [1]
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S59883
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphedema
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Breast Neoplasm
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Condition category
Condition code
Cancer
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Breast
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Extracellular fluid in the arm
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Assessment method [1]
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Bioimpedance spectroscopy (BIS) is a measurement tool used to determine the volume of extracellular fluid, of which lymph fluid is a component.
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Timepoint [1]
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immediately after inclusion in the study
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Primary outcome [2]
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Arm volume
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Assessment method [2]
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Arm circumference measures are commonly used to diagnose and monitor lymphedema.
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Timepoint [2]
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immediately after inclusion in the study
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Primary outcome [3]
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Pitting
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Assessment method [3]
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The pitting tests examines the responsiveness of tissue to pressure and can be used to help determine the stage of lymphedema.
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Timepoint [3]
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immediately after inclusion in the study
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Secondary outcome [1]
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Self-reported signs and symptoms of lymphedema
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Assessment method [1]
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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.
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Timepoint [1]
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immediately after inclusion in the study
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Secondary outcome [2]
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Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema
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Assessment method [2]
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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.
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Timepoint [2]
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immediately after inclusion in the study
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Secondary outcome [3]
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Global Health Status/Quality of Life Score
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Assessment method [3]
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Health-related quality of life assessed with the generic QLQ-C30 and the disease-specific QLQ-BR23 questionnaire
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Timepoint [3]
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immediately after inclusion in the study
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Secondary outcome [4]
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Body perception
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Assessment method [4]
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The BATH CRPS body perception disturbances scale: to assess body perception disturbances in breast cancer patients.
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Timepoint [4]
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immediately after inclusion in the study
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Secondary outcome [5]
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Pain intensity assessed with the Numeric Rating Scale
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Assessment method [5]
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Numeric Rating Scale for maximal pain intensity during the past week.
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Timepoint [5]
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immediately after inclusion in the study
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Secondary outcome [6]
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Prevalence of neuropathic pain
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Assessment method [6]
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Measured with the Douleur Neuropathique en 4 questions (DN4)
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Timepoint [6]
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immediately after inclusion in the study
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Secondary outcome [7]
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Tactile acuity (Two-point discrimination)
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Assessment method [7]
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To assess body perception two-point discrimination will be assessed at both arms, the breasts and lateral trunk side.
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Timepoint [7]
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immediately after inclusion in the study
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Secondary outcome [8]
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Mechanical detection and pain threshold
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Assessment method [8]
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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.
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Timepoint [8]
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immediately after inclusion in the study
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Secondary outcome [9]
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Temporal summation
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Assessment method [9]
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Detection of perceived temporal summation at the upper limb and upper body region tested using repeated 26g nylon monofilament stimulation.
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Timepoint [9]
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immediately after inclusion in the study
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- patients under the age of 18 years
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2020
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Sample size
Target
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Accrual to date
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Final
46
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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University of Sydney, Faculty of Health Sciences - Sydney
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Recruitment postcode(s) [1]
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2006 - Sydney
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Leuven
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Funding & Sponsors
Primary sponsor type
Other
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Name
Universitaire Ziekenhuizen KU Leuven
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03687749
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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An De Groef, PhD
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Address
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Universitaire Ziekenhuizen KU Leuven
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03687749
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