Patient Anxiety Associated With Lymphedema Surveillance Method

Anxiety Clinical Trial

Official title:

A Study of Patient Anxiety Associated With Lymphedema Surveillance: Comparing Volumetric Analysis and Bio-Impedance Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033759
• Other study ID #: Anxiety & Lymphedema
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: March 19, 2019

Study information

• Verified date: June 2020
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 19, 2019
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria:

• Those women with a pacemaker

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Lymphedema

Intervention

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

Other:
• Anxiety Questionnaire
21 item questionnaire
• Traditional Circumferential Measurements

Locations

Country	Name	City	State
United States	Mercy Clarkson/Clayton	Creve Coeur	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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