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Clinical Trials/NCT02073045
NCT02073045
Terminated
Not Applicable

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

Case Comprehensive Cancer Center1 site in 1 country17 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Case Comprehensive Cancer Center
Enrollment
17
Locations
1
Primary Endpoint
Improvement in participant's knowledge of lymphedema
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Improvement in participant's knowledge of lymphedema

Time Frame: Baseline to 3 months post-surgery

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.

Total girth differences as assessed by BUE circumferential measurements using the National Lymphedema Network (NLN) guidelines

Time Frame: Baseline to 3 months post-surgery

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.

Study Sites (1)

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