Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers
2015年9月3日 更新者：Memorial Sloan Kettering Cancer Center
A Comparison of Strategies for Injection Teaching: Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers
The purpose of this study is to compare two different ways of teaching people how to give injections at home.
The first is what we do now, which is teaching patients and/or their caregivers verbally and by giving written instructions.
The second is what we do now (verbal and written instructions) along with a demonstration and practice using a needle and an injection pad that feels similar to skin and fat.
This is being done to find the best method for teaching people to give an injection at home.
研究概览
研究类型
观察性的
注册 (实际的)
51
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
All breast cancer medical oncology clinics at MSKCC will serve as recruitment clinics for the proposed study.
Nurses will notify the PI of any patient due to start adjuvantadjuvant or neoadjuvant treatment when the regimen includes pegfilgrastim.
描述
Inclusion Criteria:
- English speaking
- Over 18 years of age
- No history of performing injections
- Patient must be receiving pegfilgrastim during adjuvant or neoadjuvant chemotherapy
- Patient will have the pegfilgrastim administered at home either by self administering or by a caregiver.
Exclusion Criteria:
- Patient or caregiver desire to inject (with saline) during or immediately following the injection teaching
- Prior self-injection or injection administration experience of any type
- Patients with history of anaphylaxis or other severe reactions to latex
- Patients that required pegfilgrastim injection be administered in clinic
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
control injection teaching
The first 25 subjects recruited into the study will be that control group.
Subjects accrued during the control phase will receive the control injection teaching, which at MSKCC is verbal instruction.
To minimize practice variation, the teaching will be provided by the office-practice nurse guided by a verbal script.
The consented subjects will complete a questionnaire before the teaching, immediately after the teaching, and after performing the injection the following day.
The nurse who administered the teaching will also complete an evaluation immediately following the teaching.
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Pre-teaching Evaluation: Patient
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intervention group
The subsequent 25 subjects enrolled into the study will be in the intervention group.
Subjects accrued during the intervention phase will receive the verbal and written injection teaching, plus demonstration and return demonstration using an injection model.
It is anticipated that the intervention teaching will take no longer then 5 additional minutes, however time will be evaluated as a secondary objective as well in both groups.
The consented subjects will complete a questionnaire before the teaching, immediately after the teaching, and after performing the injection the following day.
The nurse who administered the teaching will also complete an evaluation immediately following the teaching.
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Post-injection Evaluation: Patient
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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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compare verbal and written teaching for injection teaching
大体时间：1 year
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with verbal and written teaching + simulation using an injection model, in terms of:
|
1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assess for changes in patient self-reported
大体时间：1 year
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worry about injection before and after the injection teaching
|
1 year
|
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Compare nurses' perceptions of patient/caregiver confidence levels
大体时间：1 year
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after injection teaching to actual patient/caregiver reported confidence levels
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1 year
|
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Compare the amount of nurses' time spent teaching
大体时间：1 year
|
between the teaching modalities
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1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Erica Fischer-Cartlidge, RN, MSN、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2013年4月9日
首先提交符合 QC 标准的
2013年4月9日
首次发布 (估计)
2013年4月11日
研究记录更新
最后更新发布 (估计)
2015年9月4日
上次提交的符合 QC 标准的更新
2015年9月3日
最后验证
2015年9月1日
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.