Patient Anxiety Associated With Lymphedema Surveillance Method

Mercy Research

Status: Completed

Conditions: Anxiety

Treatments: Other: Traditional Circumferential Measurements; Device: Bio-Impedance Testing; Other: Anxiety Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT02033759

Anxiety & Lymphedema

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women recently diagnosed with breast cancer Age 18 and older

Exclusion criteria

• Those women with a pacemaker

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Traditional circumferential measurements

Active Comparator group

Description:

Traditional screening with volumetric analysis Patient Anxiety Questionnaire

Treatment:

Other: Anxiety Questionnaire

Other: Traditional Circumferential Measurements

Bio-Impedance Testing

Experimental group

Description:

Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire

Treatment:

Other: Anxiety Questionnaire

Device: Bio-Impedance Testing

Other: Traditional Circumferential Measurements