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Patient Anxiety Associated With Lymphedema Surveillance Method

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02033759
Recruitment Status : Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
We propose to study the impact of BIA screening on anxiety and primary prevention strategies for lymphedema development among patients with recent surgery for breast cancer. Currently, professional societies recommend scheduled follow-up visits to screen for lymphedema after recovery from breast cancer (e.g., 6-week, 3-month, 6-month visits with a certified lymphedema therapist). Screening involves a discussion of lymphedema symptoms and risk reduction strategies, measurement of the affected limb with a tape measure, and physical inspection for physical changes consistent with lymphedema. In the proposed study, patients will be randomly assigned to the addition of BIA screening vs. usual care. At each screening visit, all patients will be assessed for their current lymphedema risk behaviors, as outlined by the National Lymphedema Network (7). To evaluate anxiety levels, all patients will be asked to fill out the Beck Anxiety Inventory, a validated screening tool used in prior studies of patients with breast cancer (8,9). This questionnaire will be administered at each follow-up lymphedema screening visit, and the baseline will be administered at the preoperative visit. For patients randomly assigned to BIA screening, this involves the placement of adhesive electrodes on the each wrist and an ankle, followed by connection of the electrodes to the BIA machine, which then uses a painless electrical impulse to measure impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2 upper limbs (6,10). Statistical analysis will involve comparison of lymphedema risk behaviors and anxiety levels between those patients with vs. without BIA screening.

Condition or disease Intervention/treatment
Anxiety Device: Bio-Impedance Testing Other: Anxiety Questionnaire Other: Traditional Circumferential Measurements

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Study of Patient Anxiety Associated With Lymphedema Surveillance: Comparing Volumetric Analysis and Bio-Impedance Analysis
Study Start Date : June 2014
Primary Completion Date : September 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Lymphedema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Traditional circumferential measurements
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Other: Anxiety Questionnaire
21 item questionnaire
Other Name: Beck Anxiety Inventory will be administered.
Other: Traditional Circumferential Measurements
Experimental: Bio-Impedance Testing
Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire
Device: Bio-Impedance Testing
Participants in the BIA Arm will also undergo bio-impedance testing with this device.
Other Name: LTU-400 by Impedimed
Other: Anxiety Questionnaire
21 item questionnaire
Other Name: Beck Anxiety Inventory will be administered.
Other: Traditional Circumferential Measurements

Outcome Measures

Primary Outcome Measures :
  1. Anxiety [ Time Frame: Pre-operative-6mos. post breast surgery ]
    Numeric score on Beck Anxiety Inventory

Secondary Outcome Measures :
  1. Upper Extremity Limb Volume [ Time Frame: at enrollment (pre-op), 6 weeks post-op, 3 and 6 months post-op ]
    Calculated in milliliters from circumferential measurements

Other Outcome Measures:
  1. Bio-Impedance LDEX value [ Time Frame: pre-op, 6 weeks post op, 3 months and 6 months post-op ]
    LDEX reading (numeric) from device

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria:

- Those women with a pacemaker

Contacts and Locations

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): NCT02033759

United States, Missouri
Mercy Clarkson/Clayton
Ballwin, Missouri, United States, 63011
Sponsors and Collaborators
Mercy Integrative Medicine
More Information

Responsible Party: Sarah Stolker, MSPT, Physical Therapist, Mercy Integrative Medicine
ClinicalTrials.gov Identifier: NCT02033759     History of Changes
Other Study ID Numbers: Anxiety & Lymphedema
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Sarah Stolker, MSPT, Mercy Integrative Medicine:

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Lymphatic Diseases