Patient Anxiety Associated With Lymphedema Surveillance Method

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Anxiety Questionnaire; Other: Traditional Circumferential Measurements; Device: Bio-Impedance Testing

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Mercy Clarkson/Clayton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria:

- Those women with a pacemaker

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mercy Research

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): March 19, 2019

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Lymphedema
• Additional Relevant MeSH Terms: Mental Disorders; Lymphatic Diseases; Lymphedema; Anxiety Disorders
• Other Study ID Numbers: Anxiety & Lymphedema

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: POSTER PRESENTATION AT ACRM CONFERENCE CHICAGO NOV 2016