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NCT02033759 · ClinicalTrials.gov registry record · NA
Patient Anxiety Associated With Lymphedema Surveillance Method
A NA study, sponsored by Mercy Research.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT02033759 is a NA study that has completed, run by Mercy Research. The registered enrollment target is 43 participants.
The verdict
NCT02033759, a NA study, has completed, sponsored by Mercy Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study 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
- DEVICE Bio-Impedance Testing
- OTHER Anxiety Questionnaire
- OTHER Traditional Circumferential Measurements
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2014-06 |
| Est. Completion | 2019-03-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02033759
The ClinicalTrials.gov registry entry for NCT02033759 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mercy Research, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bio-Impedance Testing is the first listed.
NCT02033759 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02033759 about?
NCT02033759 is a clinical study titled "Patient Anxiety Associated With Lymphedema Surveillance Method". 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 can...
What is the current status of trial NCT02033759?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2014-06. Estimated completion is 2019-03-19.
What interventions are being tested in trial NCT02033759?
The interventions under investigation include: Bio-Impedance Testing (DEVICE), Anxiety Questionnaire (OTHER), Traditional Circumferential Measurements (OTHER).
Who is sponsoring clinical trial NCT02033759?
This trial is sponsored by Mercy Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
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