Trial Outcomes & Findings for Patient Anxiety Associated With Lymphedema Surveillance Method (NCT NCT02033759)
NCT ID: NCT02033759
Last Updated: 2020-07-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
6 weeks post-op
Results posted on
2020-07-13
Participant Flow
Participant milestones
| Measure |
Traditional Circumferential Measurements
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Anxiety Questionnaire: 21 item questionnaire
Traditional Circumferential Measurements
|
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
Traditional Circumferential Measurements
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Traditional Circumferential Measurements
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Anxiety Questionnaire: 21 item questionnaire
Traditional Circumferential Measurements
|
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
Traditional Circumferential Measurements
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Patient was excluded due to exclusion criteria
Baseline characteristics by cohort
| Measure |
Traditional Circumferential Measurements
n=19 Participants
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).
|
Bio-Impedance Testing
n=19 Participants
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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Patient was excluded due to exclusion criteria
|
0 Participants
n=7 Participants • Patient was excluded due to exclusion criteria
|
0 Participants
n=5 Participants • Patient was excluded due to exclusion criteria
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants • Patient was excluded due to exclusion criteria
|
11 Participants
n=7 Participants • Patient was excluded due to exclusion criteria
|
24 Participants
n=5 Participants • Patient was excluded due to exclusion criteria
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants • Patient was excluded due to exclusion criteria
|
8 Participants
n=7 Participants • Patient was excluded due to exclusion criteria
|
14 Participants
n=5 Participants • Patient was excluded due to exclusion criteria
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Body Mass Index
|
30 BMI (kg/m^2) Average
n=5 Participants
|
29 BMI (kg/m^2) Average
n=7 Participants
|
30 BMI (kg/m^2) Average
n=5 Participants
|
|
Anxiety
|
7.2 units on a scale
n=5 Participants
|
12.2 units on a scale
n=7 Participants
|
9.6 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-opThe 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.
Outcome measures
| Measure |
Traditional Circumferential Measurements
n=19 Participants
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Anxiety Questionnaire: 21 item questionnaire
Traditional Circumferential Measurements
|
Bio-Impedance Testing
n=19 Participants
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
Traditional Circumferential Measurements
|
|---|---|---|
|
Anxiety
|
7.1 units on a scale
Interval 0.0 to 23.0
|
8.8 units on a scale
Interval 0.0 to 31.0
|
PRIMARY outcome
Timeframe: 3 months post-opThe 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.
Outcome measures
| Measure |
Traditional Circumferential Measurements
n=19 Participants
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Anxiety Questionnaire: 21 item questionnaire
Traditional Circumferential Measurements
|
Bio-Impedance Testing
n=19 Participants
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
Traditional Circumferential Measurements
|
|---|---|---|
|
Anxiety
|
7.8 units on a scale
Interval 0.0 to 26.0
|
10.1 units on a scale
Interval 0.0 to 39.0
|
PRIMARY outcome
Timeframe: 6 months post-opThe 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.
Outcome measures
| Measure |
Traditional Circumferential Measurements
n=19 Participants
Traditional screening with volumetric analysis Patient Anxiety Questionnaire
Anxiety Questionnaire: 21 item questionnaire
Traditional Circumferential Measurements
|
Bio-Impedance Testing
n=19 Participants
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
Traditional Circumferential Measurements
|
|---|---|---|
|
Anxiety
|
5.1 units on a scale
Interval 0.0 to 15.0
|
6.6 units on a scale
Interval 0.0 to 20.0
|
Adverse Events
Traditional Circumferential Measurements
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bio-Impedance Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Stolker, MSPT, CLT-LANA
Mercy Integrative Medicine
Phone: 13145402858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place