嵌入式姑息治疗治疗复发性 III-IV 期胸部恶性肿瘤患者及其护理人员的症状
晚期胸部恶性肿瘤管理中的嵌入式姑息治疗
This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.
研究概览
地位
条件
详细说明
PRIMARY OBJECTIVES:
I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.
II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.
III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.
IV. To analyze health care utilization among participants receiving embedded onco-palliative care.
OUTLINE:
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.
After completion of study, patients are followed for up to 1 year.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ohio
-
Columbus、Ohio、美国、43210
- Ohio State University Comprehensive Cancer Center
-
-
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:
- Patients with advanced or metastatic cancer of the chest (lung, thymus, or pleura): stage III or IV, recurrent disease
- Patients will receive therapy (chemotherapy, immunotherapy, targeted therapy or radiation therapy) at The Ohio State University
- New patients (defined as patients who have received no therapy for metastatic disease or have started treatment for metastatic disease within the last 30 days) or established patients with advanced cancer receiving anti-cancer therapy, no limit on prior therapies
- Patient and caregiver must be able to read and understand consent form
- Patients must designate a willing caregiver to participate although caregiver consent is not required for patient participation
Exclusion Criteria:
- Patients who are already enrolled or have been previously enrolled in palliative care or hospice services as an outpatient. Inpatient palliative care consultation prior to enrollment is permitted
- Patients who do not qualify for active anti-cancer therapy and opt to enroll in hospice services prior to study enrollment
- Patients who are unable to read or understand consent form
- Patients receiving primary systemic treatment outside of Ohio State. Outside radiation therapy is permitted
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 |
|---|---|
|
实验性的：Supportive care (embedded palliative care)
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit. |
Ancillary studies Undergo embedded palliative care
其他名称：
|
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 |
|---|---|---|
|
Acceptance from providers to assess utilization of palliative care services
大体时间：Up to 12 months
|
Acceptance will be evaluated utilizing provider surveys (to capture provider opinions on palliative care utilization) as well as rate of enrollment. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Demand of palliative care services to be evaluated
大体时间：Up to 12 months
|
Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Capacity and productivity to be evaluated
大体时间：Up to 12 months
|
Clinician capacity and productivity will be evaluated by looking at scheduling as well as billing productivity. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Resource assessment of staff and space
大体时间：Up to 12 months
|
Resources required, including patient care rooms and nursing support will also be evaluated. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Symptom burden (patient outcome) supportive care screen
大体时间：Up to 12 months
|
Will be assessed using Supportive care screen. |
Up to 12 months
|
|
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
大体时间：Up to 12 months
|
Will be assessed using Functional Assessment of Cancer Therapy-Lung |
Up to 12 months
|
|
Symptom burden (patient outcome) using HADS
大体时间：Up to 12 months
|
Will be assessed using Hospital Anxiety and Depression Scale (HADS) |
Up to 12 months
|
|
Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
大体时间：Up to 12 months
|
Will be assessed using National Comprehensive Cancer Network distress thermometer |
Up to 12 months
|
|
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
大体时间：Up to 12 months
|
Anxiety assessed using the Hospital Anxiety and Depression Scale |
Up to 12 months
|
|
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
大体时间：Up to 12 months
|
Depression assessed using the Hospital Anxiety and Depression Scale |
Up to 12 months
|
|
Functional status assessed using Functional Activities Scale (patient outcome)
大体时间：Up to 12 months
|
Functional status assessment using Functional Activities Scale (FAS) |
Up to 12 months
|
|
Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)
大体时间：Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
大体时间：Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Work/social needs assessed using SCNS- P and C (Caregiver outcome)
大体时间：Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Information needs assessed using SCNS- P and C (Caregiver outcome)
大体时间：Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)
大体时间：Up to 12 months
|
Ohio State Palliative Care Provider survey used to assess perceived barriers to referral |
Up to 12 months
|
|
Health care utilization outcomes
大体时间：Up to 12 months
|
Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events. |
Up to 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model
大体时间：Up to 12 months
|
evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care |
Up to 12 months
|
合作者和调查者
调查人员
- 首席研究员：Carolyn Presley, MD、Ohio State University Comprehensive Cancer Center
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- OSU-18116
- NCI-2018-01209 (注册表标识符：CTRP (Clinical Trial Reporting Program))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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