Studying Survivorship Care Plans in Head and Neck Cancer
2020年1月14日 更新者：Duke University
Comparison of Enhanced Survivorship Care Plans in a Head and Neck Cancer Clinic to Standard of Care
The study will focus on survivorship care for head and neck cancer patients cared for within Duke Cancer Center clinics.
Standardized survivorship care plans (sSCP) are being implemented based on the American Society for Clinical Oncology's criteria.
These documents provide a summary of treatment received, and list side effects and follow-up information after cancer treatment.
Taking advantage of this transition, the investigator will study three groups of patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors treated after the sSCP was implemented, and (c) current patients who will receive an individualized enhanced SCP (eSCP), which will include additional information tailored to patient preferences.
The investigators hypothesize that patients receiving enhanced survivorship care plans will increase their knowledge regarding their health care plan and wellness trajectory; increase their ability to identify the symptoms they most likely can expect as a result of their cancer treatment; and be more likely to engage in conversations with their PCP about healthy behaviors and screening guidelines.
研究概览
研究类型
介入性
注册 (实际的)
6
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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North Carolina
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Durham、North Carolina、美国、27710
- Duke Health, Duke 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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Completed treatment for a head or neck cancer at Duke Cancer Center within 4 months of consent OR
- Will complete treatment for a head and neck cancer at Duke Cancer Center within 3 weeks of consent AND
- Able to read and understand English
- Capable of giving informed consent
- Are at least age 18.
Exclusion Criteria:
- incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer; or too sick to participate, as judged by a member of the research team
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：非随机化
- 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 |
|---|---|
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无干预：No SCP Control
Patients returning for early follow-up who did not receive SCP.
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无干预：SOC SCP Control
Patients returning for early follow-up who received a standard of care SCP.
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实验性的：eSCP Intervention
Patients currently receiving treatment who will be enrolled to receive an "enhanced" SCP (eSCP) with additional information beyond ASCO guidelines tailored to patient concerns and preferences.
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The eSCP includes a treatment summary section, a section detailing follow-up and test recommendations, a section on anticipated and potential side effects, as well as additional information specific to their experience/concerns.
They will receive a patient education notebook outlining symptoms and their management that is tailored to those that the subject may be likely to experience during their survivorship care trajectory.
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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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Head and Neck Cancer Survivor Knowledge
大体时间：5 minutes to complete 3 months after treatment end
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Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale
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5 minutes to complete 3 months after treatment end
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Change in Head and Neck Cancer Survivor Knowledge
大体时间：5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale in intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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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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Distress in head and neck cancer survivors
大体时间：5 minutes to complete 3 months after treatment end
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Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist
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5 minutes to complete 3 months after treatment end
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Distress in head and neck cancer survivors
大体时间：5 minutes to complete 3 months after treatment end
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Assesses distress through the use of the NCCN Distress Thermometer
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5 minutes to complete 3 months after treatment end
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Change in distress for head and neck cancer survivors
大体时间：5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Change in distress for head and neck cancer survivors
大体时间：5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses distress through the use of the NCCN Distress Thermometer in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Uncertainty in head and neck cancer survivors
大体时间：5 minutes to complete 3 months after treatment end
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Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form
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5 minutes to complete 3 months after treatment end
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Change in uncertainty in head and neck cancer survivors
大体时间：5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Quality of life in head and neck cancer survivors
大体时间：5 minutes to complete 3 months after treatment end
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Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35)
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5 minutes to complete 3 months after treatment end
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Change in quality of life in head and neck cancer survivors
大体时间：5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35) in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Self-efficacy in head and neck cancer survivors
大体时间：5 minutes to complete 3 months after treatment end
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Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
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5 minutes to complete 3 months after treatment end
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Change in self-efficacy in head and neck cancer survivors
大体时间：5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Information processing in head and neck cancer survivors
大体时间：5 minutes to complete 3 months after treatment end
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Assesses information processing in cancer patients through the use of the EORTC QLQ Information Module (QLQ INFO25)
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5 minutes to complete 3 months after treatment end
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Change in information processing in head and neck cancer survivors
大体时间：5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Survivorship care plan perceptions in head and neck cancer survivors
大体时间：5 minutes to complete 3 months after treatment end
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Using open ended questions during a qualitative interview, survivors will provide their perception of how survivorship care plans were useful or not in their care
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5 minutes to complete 3 months after treatment end
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Survivorship needs after treatment completion -- primary care provider documentation
大体时间：10 minutes to complete documentation review of 6 months of PCP records
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Using a documentation checklist developed by the study team, discussions on survivorship needs when returning to clinic will be assessed with a focus on symptom management or incorporation of healthy behaviors to reduce cancer recurrence
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10 minutes to complete documentation review of 6 months of PCP records
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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：Deborah H Allen, PhD, RN、Duke Health
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)
2017年4月19日
初级完成 (实际的)
2020年1月2日
研究完成 (实际的)
2020年1月2日
研究注册日期
首次提交
2017年3月29日
首先提交符合 QC 标准的
2017年4月4日
首次发布 (实际的)
2017年4月10日
研究记录更新
最后更新发布 (实际的)
2020年1月18日
上次提交的符合 QC 标准的更新
2020年1月14日
最后验证
2020年1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.