Patient Anxiety Associated With Lymphedema Surveillance Method

NCT ID: NCT02033759

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2019-03-19

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Traditional circumferential measurements

Traditional screening with volumetric analysis Patient Anxiety Questionnaire

Group Type: ACTIVE_COMPARATOR

Anxiety Questionnaire

Intervention Type: OTHER

21 item questionnaire

Traditional Circumferential Measurements

Intervention Type: OTHER

Bio-Impedance Testing

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

Group Type: EXPERIMENTAL

Bio-Impedance Testing

Intervention Type: DEVICE

Participants in the BIA Arm will also undergo bio-impedance testing with this device.

Anxiety Questionnaire

Intervention Type: OTHER

21 item questionnaire

Traditional Circumferential Measurements

Intervention Type: OTHER

Interventions

Bio-Impedance Testing

Participants in the BIA Arm will also undergo bio-impedance testing with this device.

Intervention Type: DEVICE

Anxiety Questionnaire

21 item questionnaire

Intervention Type: OTHER

Traditional Circumferential Measurements

Intervention Type: OTHER

Other Intervention Names

LTU-400 by Impedimed; Beck Anxiety Inventory will be administered.

Eligibility Criteria

Inclusion Criteria

• Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria

• Those women with a pacemaker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mercy Research

OTHER

Sponsor Role: lead

Responsible Party

Sarah Stolker

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mercy Clarkson/Clayton

Creve Coeur, Missouri, United States

Countries

United States

Other Identifiers

Anxiety & Lymphedema

Identifier Type: -

Identifier Source: org_study_id