PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

Study Overview
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Brief Summary
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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
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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

Official Title
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PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

Conditions
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Lymphedema

Intervention / Treatment
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* Other: Cohort I (patients receiving annual lymphedema screening
* Other: Cohort II (patients followed intensively for lymphedema)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a Cohort A: Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection English speaker Patients who participate in Cohort A will be eligible for enrollment in Cohort b Cohort I: Breast cancer patients who have undergone axillary lymph node dissection who have a clinic visit in the Nellie B. Connally Breast Center approximately 12 months (+/- 4 months) following axillary lymph node dissection English speaker c Cohort II: Breast cancer patients who have undergone axillary lymph node dissection who are having a follow-up visit in the Nellie B. Connally Breast Center within 0-6 months following surgery who intend to continue follow-up care at MD Anderson English speaker Exclusion Criteria: Inability to complete a self-administered questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort I (patients receiving annual lymphedema screening)<br>We will retrospectively retrieve information on patients who previously underwent preoperative perometer lymphedema screening during the past year who were treated definitively for their breast cancer with an ALND, and for whom no follow-up postoperative lymphedema screening was done. | Other: Cohort I (patients receiving annual lymphedema screening<br>* patientns who previously underwent preoperative perometer lymphedema screening<br>|
| Other: Cohort II (patients followed intensively for lymphedema)<br>We will prospectively follow a cohort of 279 patients who have recently undergone ALND in this upcoming year with intensive lymphedema screening. | Other: Cohort II (patients followed intensively for lymphedema)<br>* patients who have recently undergone ALND<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer. |  | through study completion, an average of 1 year |