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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ohio
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Cleveland、Ohio、美国、44106-5065
- Case Comprehensive Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Receive educational handouts
其他名称：
Ancillary studies
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in participant's knowledge of lymphedema
大体时间：Baseline to 3 months post-surgery
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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.
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Baseline to 3 months post-surgery
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Total girth differences as assessed by BUE circumferential measurements using the National Lymphedema Network (NLN) guidelines
大体时间：Baseline to 3 months post-surgery
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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.
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Baseline to 3 months post-surgery
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合作者和调查者
调查人员
- 首席研究员：Dotti Thompson、Case Comprehensive Cancer Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
educational intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人