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

Primary Purpose

Breast Cancer, Lymphedema

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
lymphedema survey
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (lymphedema education)

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2014
Last Updated
October 22, 2015
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02073045
Brief Title
Intensive Education in Increasing Understanding of Lymphedema in Patients With Breast Cancer Undergoing Surgery
Official Title
Effect of Intensive Education on Breast Cancer Patient's Understanding of Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
research cancelled
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (lymphedema education)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive educational handouts
Intervention Type
Other
Intervention Name(s)
lymphedema survey
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Improvement in participant's knowledge of lymphedema
Description
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.
Time Frame
Baseline to 3 months post-surgery
Title
Total girth differences as assessed by BUE circumferential measurements using the National Lymphedema Network (NLN) guidelines
Description
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.
Time Frame
Baseline to 3 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dotti Thompson
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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

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