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
Among 168 studies in Lymphedema with a site in United States — 38 open to participants now, 45 under way, 1 of them phase 3. Lymphedema · United States.
Among the 168 studies in Lymphedema with a site in United States, this one is the 68th largest by enrollment of the 122 interventional ones, is one of 5 that started in 2014, is one of 86 with no phase, and was the 61st registered.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's enrollment of 43 is below the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →38 of the 168 studies in Lymphedema with a site in United States are open now, in 11 countries. Each count lists the studies.
Of the 85 Lymphedema studies recruiting now, 46 (54%) set no upper age limit and 21 (25%) stop at 75 or younger; 5 take children under 18; 12 take healthy volunteers.
This study: 18 Years to 85 Years · female · no healthy volunteers.
The full table on the hub →168 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 5 started in 2014.
Median enrollment 50 across the 122 interventional studies, 148 across the 44 observational. Of the 114 that completed or were terminated, 39 (34%) have results posted.
29 of 168 have an industry lead sponsor. The 10 most frequent:
Mercy Research is the lead sponsor of 17 studies on the registry; none are open to participants now.
Mercy Research has 1 study filed under Lymphedema — fewer than ten, so there is no comparison to draw.
14 of the studies in Lymphedema with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05056207M.D. Anderson Cancer CenterPREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema | 2026-11-17 |
| NCT06900023Massachusetts General HospitalThe BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer | 2026-12 |
| NCT05825157Stanford UniversityEvaluation of Combination Therapy for Upper Extremity Lymphedema | 2027-01-01 |
| NCT02743858Memorial Sloan Kettering Cancer CenterLymphedema Surveillance Study | 2027-04 |
| NCT07012642Advanced Reconstructive Surgery AllianceEfficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema | 2027-04-09 |
Among the 168 studies in Lymphedema with a site in United States, from their registry updates:
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.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's enrollment of 43 is below the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Mercy Research is the lead sponsor of 17 studies on the registry; none are open to participants now.
Compared within Lymphedema, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
No publications or documents are linked to this record.
The record gives a start of Jun 2014, a primary completion of Sep 2016 and a completion of Mar 2019. It does not say whether these dates are actual or estimated.
Results were first posted in May 2020, 3 years 8 months after primary completion.
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Mercy Research