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Trial record 8 of 128 for:    lymphedema | Recruiting, Not yet recruiting, Available Studies

Presentation of First Time Attenders at Lymphedema Clinics

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ClinicalTrials.gov Identifier: NCT03687749
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.


Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

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.



Primary Outcome Measures :
  1. Extracellular fluid in the arm [ Time Frame: immediately after inclusion in the study ]
    Bioimpedance spectroscopy (BIS) is a measurement tool used to determine the volume of extracellular fluid, of which lymph fluid is a component.

  2. Arm volume [ Time Frame: immediately after inclusion in the study ]
    Arm circumference measures are commonly used to diagnose and monitor lymphedema.

  3. Pitting [ Time Frame: immediately after inclusion in the study ]
    The pitting tests examines the responsiveness of tissue to pressure and can be used to help determine the stage of lymphedema.


Secondary Outcome Measures :
  1. Self-reported signs and symptoms of lymphedema [ Time Frame: immediately after inclusion in the study ]
    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.

  2. Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema [ Time Frame: immediately after inclusion in the study ]
    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.

  3. Global Health Status/Quality of Life Score [ Time Frame: immediately after inclusion in the study ]
    Health-related quality of life assessed with the generic QLQ-C30 and the disease-specific QLQ-BR23 questionnaire

  4. Body perception [ Time Frame: immediately after inclusion in the study ]
    The BATH CRPS body perception disturbances scale: to assess body perception disturbances in breast cancer patients.

  5. Pain intensity assessed with the Numeric Rating Scale [ Time Frame: immediately after inclusion in the study ]
    Numeric Rating Scale for maximal pain intensity during the past week.

  6. Prevalence of neuropathic pain [ Time Frame: immediately after inclusion in the study ]
    Measured with the Douleur Neuropathique en 4 questions (DN4)

  7. Tactile acuity (Two-point discrimination) [ Time Frame: immediately after inclusion in the study ]
    To assess body perception two-point discrimination will be assessed at both arms, the breasts and lateral trunk side.

  8. Mechanical detection and pain threshold [ Time Frame: immediately after inclusion in the study ]
    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.

  9. Temporal summation [ Time Frame: immediately after inclusion in the study ]
    Detection of perceived temporal summation at the upper limb and upper body region tested using repeated 26g nylon monofilament stimulation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687749


Contacts
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Contact: An De Groef, PhD +32 16 342 171 an.degroef@kuleuven.be

Locations
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Australia, New South Wales
University of Sydney, Faculty of Health Sciences Recruiting
Sydney, New South Wales, Australia, 2006
Contact: Elizabeth Dylke, PhD    +61 2 9351 9021    elizabeth.dylke@sydney.edu.au   
Belgium
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Contact: An De Groef    003216342171    an.degroef@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
University of Sydney
Investigators
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Principal Investigator: An De Groef, PhD Universitaire Ziekenhuizen Leuven
Principal Investigator: Elizabeth Dylke, PhD University of Sydney, Faculty of Health Sciences

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03687749     History of Changes
Other Study ID Numbers: S59883
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases