N/A
N=43
Patient Anxiety Associated With Lymphedema Surveillance Method
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02033759 ↗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
| Outcome | Result | p-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
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.