Trials / Active Not Recruiting
Active Not RecruitingNCT05056207
PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 260 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.
Detailed description
Primary Objectives: * To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade lymphedema among breast cancer patients after ALND compared to routine screening. Secondary Objectives: * To estimate the direct costs associated with the Lymphedema Screening Initiative * To determine the association of the Initiative on patient productivity * To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care * To determine patient understanding of lymphedema-associated symptoms * To determine patient self-reported compliance with treatments and measures to prevent lymphedema * To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND To analyze clinical and pathological features associated with the development of lymphedema
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Cohort I (patients receiving annual lymphedema screening | patientns who previously underwent preoperative perometer lymphedema screening |
| OTHER | Cohort II (patients followed intensively for lymphedema) | patients who have recently undergone ALND |
Timeline
- Start date
- 2017-11-17
- Primary completion
- 2026-11-17
- Completion
- 2026-11-17
- First posted
- 2021-09-24
- Last updated
- 2026-03-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05056207. Inclusion in this directory is not an endorsement.