Patient Anxiety Associated With Lymphedema Surveillance Method

Study Overview
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Brief Summary
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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.

Official Title
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A Study of Patient Anxiety Associated With Lymphedema Surveillance: Comparing Volumetric Analysis and Bio-Impedance Analysis

Conditions
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Anxiety

Intervention / Treatment
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* Device: Bio-Impedance Testing
* Other: Anxiety Questionnaire
* Other: Traditional Circumferential Measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women recently diagnosed with breast cancer Age 18 and older Exclusion Criteria: - Those women with a pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety. | 6 weeks post-op | 
| Anxiety | The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety. | 3 months post-op | 
| Anxiety | The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety. | 6 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema