PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Lymphedema

Treatments: Other: Cohort II (patients followed intensively for lymphedema); Other: Cohort I (patients receiving annual lymphedema screening

Study type: Interventional

Funder types: Other

Identifiers

NCT05056207

NCI-2019-02478 (Other Identifier)

2017-0639

Details and patient eligibility

About

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.

Full 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

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

260 participants in 2 patient groups

Cohort I (patients receiving annual lymphedema screening)

Other group

Description:

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.

Treatment:

Other: Cohort I (patients receiving annual lymphedema screening

Cohort II (patients followed intensively for lymphedema)

Other group

Description:

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

Treatment:

Other: Cohort II (patients followed intensively for lymphedema)