Patient Anxiety Associated With Lymphedema Surveillance Method

NCT02033759 | Completed Results

• 1 other identifier: Anxiety & Lymphedema
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

Lymphedema

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Traditional circumferential measurements

ACTIVE COMPARATOR

Traditional screening with volumetric analysis Patient Anxiety Questionnaire

Other: Anxiety Questionnaire; Other: Traditional Circumferential Measurements

Bio-Impedance Testing

EXPERIMENTAL

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

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

Interventions

Bio-Impedance Testing DEVICE

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

Also known as: LTU-400 by Impedimed

Bio-Impedance Testing

Anxiety Questionnaire OTHER

21 item questionnaire

Also known as: Beck Anxiety Inventory will be administered.

Bio-Impedance Testing; Traditional circumferential measurements

Traditional Circumferential Measurements OTHER

Bio-Impedance Testing; Traditional circumferential measurements

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women recently diagnosed with breast cancer Age 18 and older

You may not qualify if:

• \- Those women with a pacemaker

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

Mercy Clarkson/Clayton

Creve Coeur, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Lymphedema

Condition Hierarchy (Ancestors)

Mental Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

Our study used the Beck Anxiety Inventory, with its greater focus on physical symptoms of anxiety, and this approach may not have been as sensitive for identifying emotional distress when compared with other psychological tools.

Results Point of Contact

• Title: Sarah Stolker, MSPT, CLT-LANA
• Organization: Mercy Integrative Medicine

sarah@stolker.com

13145402858

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 13, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: March 19, 2019
• Last Updated: July 13, 2020
• Results First Posted: May 27, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)