PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2026-11-17

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.

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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

Conditions

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Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Cohort I (patients receiving annual lymphedema screening)

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.

Group Type OTHER

Cohort I (patients receiving annual lymphedema screening

Intervention Type OTHER

patientns who previously underwent preoperative perometer lymphedema screening

Cohort II (patients followed intensively for lymphedema)

We will prospectively follow a cohort of 279 patients who have recently undergone ALND in this upcoming year with intensive lymphedema screening.

Group Type OTHER

Cohort II (patients followed intensively for lymphedema)

Intervention Type OTHER

patients who have recently undergone ALND

Interventions

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Cohort I (patients receiving annual lymphedema screening

patientns who previously underwent preoperative perometer lymphedema screening

Intervention Type OTHER

Cohort II (patients followed intensively for lymphedema)

patients who have recently undergone ALND

Intervention Type OTHER

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