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Anxiety | Patient Anxiety Associated With Lymphedema Surveillance Method

Anxiety research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Anxiety

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Bio-Impedance TestingParticipants in the BIA Arm will also undergo bio-impedance testing with this device.

Other:Anxiety Questionnaire21 item questionnaire

Other:Traditional Circumferential Measurements

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Traditional circumferential measurementsTraditional screening with volumetric analysis Patient Anxiety Questionnaire

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

Study Status

Active, not recruiting

Start Date: June 2014

Completed Date: March 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Anxiety

Secondary Outcome: Upper Extremity Limb Volume

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Mercy Integrative Medicine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02033759

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