PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

Not Applicable

Active, not recruiting

• Conditions: Lymphedema
• Interventions: Other: Cohort II (patients followed intensively for lymphedema); Other: Cohort I (patients receiving annual lymphedema screening

• Registration Number: NCT05056207
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-17
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2026-11-17
• Study Completion: 2026-11-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 260

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

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Exclusion Criteria

Inability to complete a self-administered questionnaire

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort II (patients followed intensively for lymphedema)	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.
Cohort I (patients receiving annual lymphedema screening)	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.

Primary Outcome Measures

Name	Time	Method
To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.	through study completion, an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States