- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073045
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106-5065
- Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Receive educational handouts
Other Names:
Ancillary studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 3 months post-surgery
|
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.
|
Baseline to 3 months post-surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dotti Thompson, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE1113
- P30CA043703 (U.S. NIH Grant/Contract)
- NCI-2014-00348 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CASE 1113 (Other Identifier: Case Comprehensive Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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