Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed NA study, sponsored by Mercy Research.

NCT02033759 is a NA study that has completed, run by Mercy Research. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

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.

Interventions

  • DEVICE Bio-Impedance Testing
  • OTHER Anxiety Questionnaire
  • OTHER Traditional Circumferential Measurements

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2014-06
Est. Completion 2019-03-19
Phase NA
Mercy Research

14 total trials

What the finished NCT02033759 record still lists

NCT02033759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 3 interventions - of which Bio-Impedance Testing is the first listed.

NCT02033759 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02033759's enrollment target sits among peer trials

43 1435th of 2000 higher than 565 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03726359 · 43 participants · Phase 1

    Phase I Study of Fractionated Stereotactic Radiation Therapy

  • NCT03850418 · 43 participants · Phase 2

    Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant

  • NCT04144023 · 43 participants · Phase 1

    A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

  • NCT04176718 · 43 participants · Phase 2

    Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT02033759, the US trial registry maintained by the National Library of Medicine. NCT02033759 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.