Anxiety
Conditions
Keywords
Lymphedema
Brief 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.
Interventions
DEVICEBio-Impedance Testing
Participants in the BIA Arm will also undergo bio-impedance testing with this device.
21 item questionnaire
OTHERTraditional Circumferential Measurements
Sponsors
Mercy Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Women recently diagnosed with breast cancer Age 18 and older
Exclusion criteria
\- Those women with a pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 6 weeks post-op | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional Circumferential Measurements Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Anxiety Questionnaire: 21 item questionnaire
Traditional Circumferential Measurements
Traditional screening involved circumferential measurements using a tape measure, every 4cm from the wrist to the axilla, after which a standardized computer algorithm calculated limb volume in milliliters. Significant changes were defined as \>3% volume increase when compared with the preoperative baseline limb measurements, without other clear explanation (commonly accepted unilateral volume change according to the International Society of Lymphology). | 19 |
| Bio-Impedance Testing Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire
Bio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.
Anxiety Questionnaire: 21 item questionnaire
BIS measurements involved the placement of adhesive electrodes on each wrist and the right ankle, followed by connection of the electrodes to the BIS machine (L-Dex U-400, ImpediMed Ltd). The L-Dex uses a painless electrical impulse to measure impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2 upper limbs.6, 9-13 This tool compares readings to normative data to determine if significant asymmetry exists, or if the current reading is \>2 standard deviations from the baseline reading for that individual. | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Traditional Circumferential Measurements | Bio-Impedance Testing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 11 Participants | 24 Participants |
| Anxiety | 7.2 units on a scale | 12.2 units on a scale | 9.6 units on a scale |
| Body Mass Index | 30 BMI (kg/m^2) Average | 29 BMI (kg/m^2) Average | 30 BMI (kg/m^2) Average |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
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.
Time frame: 6 weeks post-op
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Circumferential Measurements | Anxiety | 7.1 units on a scale |
| Bio-Impedance Testing | Anxiety | 8.8 units on a scale |
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.
Time frame: 3 months post-op
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Circumferential Measurements | Anxiety | 7.8 units on a scale |
| Bio-Impedance Testing | Anxiety | 10.1 units on a scale |
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.
Time frame: 6 months post-op
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Circumferential Measurements | Anxiety | 5.1 units on a scale |
| Bio-Impedance Testing | Anxiety | 6.6 units on a scale |