Intensive Education in Increasing Understanding of Lymphedema in Patients With Breast Cancer Undergoing Surgery

Study Overview
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Brief Summary
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This pilot clinical trial studies intensive education in increasing understanding of lymphedema in patients with breast cancer undergoing surgery. Lymphedema is the build-up of fluids in the arm (or other extremity) after surgery. Providing written educational handouts and verbal education on the risk factors and symptoms of lymphedema may improve patients' ability to identify symptoms of lymphedema after surgery.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the patient's increased knowledge of lymphedema signs/symptoms after education. SECONDARY OBJECTIVES: I. The participant may detect lymphedema signs/symptoms at an early stage by having a pre-surgery comparison of bilateral upper extremities (BUE) circumferential measures to the 3 month post-surgery measures. OUTLINE: Participants complete a five question survey, designed by the Occupational Therapy staff, as an instrument to assess a patient's knowledge of lymphedema signs/symptoms before surgery. An Occupational Therapist (OT), Physical Therapist (PT), and/or Certified Lymphedema Therapist (CLT) provide written handouts to participants on the pathophysiology, signs, symptoms, and treatment of lymphedema. Participants repeat the survey at 3 months post-surgery. BUE circumferential measurements are also collected before surgery and at 3 months post-surgery.

Official Title
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Effect of Intensive Education on Breast Cancer Patient's Understanding of Lymphedema

Conditions
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Breast Cancer, Lymphedema

Intervention / Treatment
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* Other: educational intervention
* Other: lymphedema survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at UH GMC Seidman Cancer Center They must understand written, verbal, and/or recorded survey questioning English Exclusion Criteria: Individuals with previous radiation treatments to the breast or axilla areas Prior diagnosis of lymphedema Persons that do not speak English Those unwilling to participate in the follow-up call 3 months post-surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (lymphedema education)<br>In an educational intervention, participants complete a five question lymphedema survey, designed by the Occupational Therapy staff, as an instrument to assess a patient's knowledge of lymphedema signs/symptoms before surgery. An OT, PT, and/or CLT provide written handouts to participants on the pathophysiology, signs, symptoms, and treatment of lymphedema. Participants repeat the survey at 3 months post-surgery. BUE circumferential measurements are also collected before surgery and at 3 months post-surgery. | Other: educational intervention<br>* Receive educational handouts<br>* Other names: intervention, educational;Other: lymphedema survey<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in participant's knowledge of lymphedema | Quantitative data regarding number of correct answers to the survey questions pre-surgery and at the post-surgery 3 month re-test will be compared to assess if the lymphedema education improved the participant's knowledge of lymphedema. | Baseline to 3 months post-surgery | 
| Total girth differences as assessed by BUE circumferential measurements using the National Lymphedema Network (NLN) guidelines | If a > 2 cm difference is noted in girth from pre to post surgery measures, a referral will be forwarded to the physician by the study investigators and treatment options provided to the participant. | Baseline to 3 months post-surgery |