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Patient Anxiety Associated With Lymphedema Surveillance Method

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bio-Impedance Testing
Anxiety Questionnaire
Traditional Circumferential Measurements
Sponsored by
Mercy Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anxiety focused on measuring Lymphedema

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria:

- Those women with a pacemaker

Sites / Locations

  • Mercy Clarkson/Clayton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional circumferential measurements

Bio-Impedance Testing

Arm Description

Traditional screening with volumetric analysis Patient Anxiety Questionnaire

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2014
Last Updated
June 25, 2020
Sponsor
Mercy Research
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1. Study Identification

Unique Protocol Identification Number
NCT02033759
Brief Title
Patient Anxiety Associated With Lymphedema Surveillance Method
Official Title
A Study of Patient Anxiety Associated With Lymphedema Surveillance: Comparing Volumetric Analysis and Bio-Impedance Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
March 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Lymphedema

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional circumferential measurements
Arm Type
Active Comparator
Arm Description
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Arm Title
Bio-Impedance Testing
Arm Type
Experimental
Arm Description
Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire
Intervention Type
Device
Intervention Name(s)
Bio-Impedance Testing
Other Intervention Name(s)
LTU-400 by Impedimed
Intervention Description
Participants in the BIA Arm will also undergo bio-impedance testing with this device.
Intervention Type
Other
Intervention Name(s)
Anxiety Questionnaire
Other Intervention Name(s)
Beck Anxiety Inventory will be administered.
Intervention Description
21 item questionnaire
Intervention Type
Other
Intervention Name(s)
Traditional Circumferential Measurements
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
6 weeks post-op
Title
Anxiety
Description
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.
Time Frame
3 months post-op
Title
Anxiety
Description
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.
Time Frame
6 months post-op

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women recently diagnosed with breast cancer Age 18 and older Exclusion Criteria: - Those women with a pacemaker
Facility Information:
Facility Name
Mercy Clarkson/Clayton
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
POSTER PRESENTATION AT ACRM CONFERENCE CHICAGO NOV 2016

Learn more about this trial

Patient Anxiety Associated With Lymphedema Surveillance Method

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