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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02073045
Enrollment
17
Registered
2014-02-27
Start date
2013-08-31
Completion date
2015-09-30
Last updated
2015-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lymphedema

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.

Interventions

OTHEReducational intervention

Receive educational handouts

OTHERlymphedema survey

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in participant's knowledge of lymphedemaBaseline to 3 months post-surgeryQuantitative 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) guidelinesBaseline to 3 months post-surgeryIf 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026