An interventional study of Bio-Impedance Testing and Anxiety Questionnaire in Anxiety, sponsored by Mercy Research. Completed at 1 site in United States. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-07-13.
Sponsored by Mercy Research · Not applicable, Interventional, and Screening
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.
Exclusion Criteria:
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Other: Anxiety Questionnaire · Other: Traditional Circumferential Measurements
Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire
Device: Bio-Impedance Testing · Other: Anxiety Questionnaire · Other: Traditional Circumferential Measurements
Participants in the BIA Arm will also undergo bio-impedance testing with this device.
Also known as: LTU-400 by Impedimed
21 item questionnaire
Also known as: Beck Anxiety Inventory will be administered.
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.
Time frame: 6 weeks post-op
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.
Time frame: 3 months post-op
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.
Time frame: 6 months post-op
| Milestone | Traditional Circumferential Measurements | Bio-Impedance Testing |
|---|---|---|
| Started | 22 | 21 |
| Completed | 19 | 19 |
| Not completed | 3 | 2 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
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.
| units on a scale | Traditional Circumferential Measurements | Bio-Impedance Testing |
|---|---|---|
| Anxiety | 7.1 (0 to 23) | 8.8 (0 to 31) |
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.
| units on a scale | Traditional Circumferential Measurements | Bio-Impedance Testing |
|---|---|---|
| Anxiety | 7.8 (0 to 26) | 10.1 (0 to 39) |
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.
| units on a scale | Traditional Circumferential Measurements | Bio-Impedance Testing |
|---|---|---|
| Anxiety | 5.1 (0 to 15) | 6.6 (0 to 20) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Traditional Circumferential Measurements | — | 0/20 (0%) | 0/20 (0%) |
| Bio-Impedance Testing | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Traditional Circumferential Measurements | Bio-Impedance Testing | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 11 | 24 |
| >=65 years | 6 | 8 | 14 |
| Sex: Female, Male(Participants) | Traditional Circumferential Measurements | Bio-Impedance Testing | Total |
|---|---|---|---|
| Female | 19 | 18 | 37 |
| Male | 0 | 1 | 1 |
| Region of Enrollment(participants) | Traditional Circumferential Measurements | Bio-Impedance Testing | Total |
|---|---|---|---|
| United States | 19 | 19 | 38 |
| Body Mass Index(BMI (kg/m^2) Average) | Traditional Circumferential Measurements | Bio-Impedance Testing | Total |
|---|---|---|---|
| Mean | 30 (24 to 40) | 29 (21 to 42) | 30 (21 to 42) |
| Anxiety(units on a scale) | Traditional Circumferential Measurements | Bio-Impedance Testing | Total |
|---|---|---|---|
| Mean | 7.2 (0 to 25) | 12.2 (0 to 34) | 9.6 (0 to 34) |
Plan to share: Yes — POSTER PRESENTATION AT ACRM CONFERENCE CHICAGO NOV 2016
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Mercy Research