Intensive Education in Increasing Understanding of Lymphedema in Patients With Breast Cancer Undergoing Surgery
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.
Other: educational intervention
Other: lymphedema survey
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Effect of Intensive Education on Breast Cancer Patient's Understanding of Lymphedema|
- Improvement in participant's knowledge of lymphedema [ Time Frame: Baseline to 3 months post-surgery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 Start Date:||August 2013|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (lymphedema education)
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
Receive educational handouts
Other Name: intervention, educationalOther: lymphedema survey
I. To assess the patient's increased knowledge of lymphedema signs/symptoms after education.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02073045
|United States, Ohio|
|Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106-5065|
|Contact: Dotti Thompson 440-285-6889 firstname.lastname@example.org|
|Principal Investigator: Dotti Thompson|
|Principal Investigator:||Dotti Thompson||Case Comprehensive Cancer Center|