Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer
2019年2月8日 更新者：Case Comprehensive Cancer Center
Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer
Patients with head and neck cancer and their caregivers face many challenges.
These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness.
This study tests whether different forms of education and support can help family caregivers feel better prepared.
To find out if education about caregiving and different kinds of support are effective, this study wants to compare approaches.One group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses.
The other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses.
The caregiver also completes surveys about his or her emotions, distress, confidence as a care giver, and quality of life.
In addition, the study asks the caregiver questions about his or her age, race, ethnicity, marital status, employment status, education, annual household income, and current living arrangements.
This pilot study will only be offered at the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Main Campus.
研究概览
详细说明
Aim 1: Conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life.
Aim 2: Explore the acceptability of a caregiver intervention that utilizes simulation.
Aim 3: Assess the feasibility of the intervention. Aim 4: Describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.
研究类型
介入性
注册 (实际的)
18
阶段
- 不适用
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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Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals Cleveland Medical Center, Case Comprehensive 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
18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
描述
Inclusion Criteria:
- family member or friend of an adult patient with a new diagnosis of Stage III - IV cancers of the tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, or parotid who is receiving radiation therapy for curative intent
- identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support
- cognitively intact, as evidenced by orientation to person, place, and time
- ability to speak, read, and comprehend English
Exclusion Criteria:
- Caregivers of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care
- Caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)
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
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention Group: Caregiver education
The intervention includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses.
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The intervention will be delivered by a radiation oncology nurse.
Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing.
其他名称：
written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
其他名称：
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有源比较器：Control Group: educational booklet
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
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written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
其他名称：
Radiation Oncology Nurse will hand participant the NCI booklet
其他名称：
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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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Average efficacy of caregiving summary score
大体时间：Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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Average anxiety summary score
大体时间：Up to 5 weeks
|
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
|
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Average depression summary score
大体时间：Up to 5 weeks
|
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
|
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Average Health Related Quality of Life (HRQOL) summary score
大体时间：Up to 5 weeks
|
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Qualitative assessment of acceptability
大体时间：Up to 5 weeks
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Descriptive statistics will be used to summarize responses to semi-structured interviews
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Up to 5 weeks
|
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Attrition rate to assess feasibility
大体时间：Up to 5 weeks
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Feasibility will be assessed via attrition and consent rates.
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Up to 5 weeks
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Consent rate to assess feasibility
大体时间：Up to 5 weeks
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Feasibility will be assessed via attrition and consent rates.
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Up to 5 weeks
|
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Total time for delivering intervention to assess costs
大体时间：Up to 5 weeks
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Time for delivering the intervention will be recorded to aid in assessing costs.
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Up to 5 weeks
|
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Average missed checklist items to assess integrity of intervention
大体时间：Up to 5 weeks
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Integrity of the intervention will be assessed through monitoring of intervention checklist.
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Up to 5 weeks
|
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Event rate for patient events
大体时间：Up to 5 weeks
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Describe the average incidence of all patient events that may be impacted by caregiver self-efficacy.
Events may include acute care visits, admission to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course, and others
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Up to 5 weeks
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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：Susan Mazanec, PhD, RN、University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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 (实际的)
2015年8月1日
初级完成 (实际的)
2018年1月12日
研究完成 (实际的)
2018年1月12日
研究注册日期
首次提交
2015年10月14日
首先提交符合 QC 标准的
2015年10月14日
首次发布 (估计)
2015年10月16日
研究记录更新
最后更新发布 (实际的)
2019年2月11日
上次提交的符合 QC 标准的更新
2019年2月8日
最后验证
2019年2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.