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

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Breast Cancer; Lymphedema

Treatments: Other: educational intervention; Other: lymphedema survey

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02073045

NCI-2014-00348 (Registry Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE 1113 (Other Identifier)

CASE1113

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Supportive care (lymphedema education)

Experimental group

Description:

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.

Treatment:

Other: lymphedema survey

Other: educational intervention