Patient Anxiety Associated With Lymphedema Surveillance Method

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Mercy Integrative Medicine
Sponsor:
Information provided by (Responsible Party):
Sarah Stolker, MSPT, Mercy Integrative Medicine
ClinicalTrials.gov Identifier:
NCT02033759
First received: January 7, 2014
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Study of Patient Anxiety Associated With Lymphedema Surveillance: Comparing Volumetric Analysis and Bio-Impedance Analysis

Resource links provided by NLM:


Further study details as provided by Mercy Integrative Medicine:

Primary Outcome Measures:
  • Anxiety [ Time Frame: Pre-operative-6mos. post breast surgery ] [ Designated as safety issue: No ]
    Numeric score on Beck Anxiety Inventory


Secondary Outcome Measures:
  • Upper Extremity Limb Volume [ Time Frame: at enrollment (pre-op), 6 weeks post-op, 3 and 6 months post-op ] [ Designated as safety issue: No ]
    Calculated in milliliters from circumferential measurements


Other Outcome Measures:
  • Bio-Impedance LDEX value [ Time Frame: pre-op, 6 weeks post op, 3 months and 6 months post-op ] [ Designated as safety issue: No ]
    LDEX reading (numeric) from device


Estimated Enrollment: 50
Study Start Date: February 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional circumferential measurements
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Other: Anxiety Questionnaire
21 item questionnaire
Other Name: 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
Device: Bio-Impedance Testing
Participants in the BIA Arm will also undergo bio-impedance testing with this device.
Other Name: LTU-400 by Impedimed
Other: Anxiety Questionnaire
21 item questionnaire
Other Name: Beck Anxiety Inventory will be administered.
Other: Traditional Circumferential Measurements

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria:

  • Those women undergoing neo-adjuvant chemotherapy
  • Those women with a pacemaker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033759

Contacts
Contact: Sarah A Stolker, MSPT 314-540-2858 sarah@stolker.com
Contact: Diane Radford, MD (324)323-4234 diane.radford@mercy.net

Locations
United States, Missouri
Mercy Clarkson/Clayton Not yet recruiting
Ballwin, Missouri, United States, 63011
Contact: Laura Boekemeier, RN    636-256-5000    laura.boekemeier@mercy.net   
Principal Investigator: Sarah A Stolker, MSPT         
Sponsors and Collaborators
Mercy Integrative Medicine
  More Information

No publications provided

Responsible Party: Sarah Stolker, MSPT, Physical Therapist, Mercy Integrative Medicine
ClinicalTrials.gov Identifier: NCT02033759     History of Changes
Other Study ID Numbers: Anxiety & Lymphedema
Study First Received: January 7, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mercy Integrative Medicine:
Lymphedema

Additional relevant MeSH terms:
Anxiety Disorders
Lymphedema
Mental Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 25, 2014