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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00348 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE 1113 | Other Identifier | Case Comprehensive Cancer Center | |
| P30CA043703 | U.S. NIH Grant/Contract | View source |
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research cancelled
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (lymphedema education) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Receive educational handouts |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 3 months post-surgery |
| 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. | Baseline to 3 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dotti Thompson | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| lymphedema survey | Other | Ancillary studies |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |