Patient Anxiety Associated With Lymphedema Surveillance Method



Status:Active, not recruiting
Conditions:Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 85
Updated:4/17/2018
Start Date:June 2014
End Date:March 2019

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

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.


Inclusion Criteria:

- Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria:

- Those women with a pacemaker
We found this trial at
1
site
615 South New Ballas Road
Creve Coeur, Missouri 63141
?
mi
from
Creve Coeur, MO
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