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N/A N=43 Randomized Screening

Patient Anxiety Associated With Lymphedema Surveillance Method

Anxiety

Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Anxiety — 7.1; 8.8 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Bio-Impedance Testing (Device); Anxiety Questionnaire (Other); Traditional Circumferential Measurements (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Mercy Research
Primary completion
Sep 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Anxiety
5.1; 6.6
PRIMARY
Anxiety
5.1; 6.6
PRIMARY
Anxiety
5.1; 6.6

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.

Eligibility Criteria

Inclusion Criteria

  • Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria

  • Those women with a pacemaker
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02033759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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