Breast Cancer Clinical Trial

PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

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.

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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

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Eligibility Criteria

Inclusion Criteria:

a Cohort A:

Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection
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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
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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

260

Study ID:

NCT05056207

Recruitment Status:

Active, not recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

260

Study ID:

NCT05056207

Recruitment Status:

Active, not recruiting

Sponsor:


M.D. Anderson Cancer Center

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