Lymphedema
Conditions
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
Interventions
OTHERCohort I (patients receiving annual lymphedema screening
patientns who previously underwent preoperative perometer lymphedema screening
OTHERCohort II (patients followed intensively for lymphedema)
patients who have recently undergone ALND
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSimona Shaitelman
M.D. Anderson Cancer Center
Outcome results
None listed