Embedded Palliative Care in the Management of Advanced Thoracic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Capacity and productivity to be evaluated
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Capacity and productivity to be evaluated
时间窗: 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.
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
时间窗: Up to 12 months
Anxiety assessed using the Hospital Anxiety and Depression Scale
Work/social needs assessed using SCNS- P and C (Caregiver outcome)
时间窗: Up to 12 months
Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)
Information needs assessed using SCNS- P and C (Caregiver outcome)
时间窗: Up to 12 months
Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)
Demand of palliative care services to be evaluated
时间窗: Up to 12 months
Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.
Symptom burden (patient outcome) supportive care screen
时间窗: Up to 12 months
Will be assessed using Supportive care screen.
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
时间窗: Up to 12 months
Will be assessed using Functional Assessment of Cancer Therapy-Lung
Symptom burden (patient outcome) using HADS
时间窗: Up to 12 months
Will be assessed using Hospital Anxiety and Depression Scale (HADS)
Functional status assessed using Functional Activities Scale (patient outcome)
时间窗: Up to 12 months
Functional status assessment using Functional Activities Scale (FAS)
Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
时间窗: Up to 12 months
Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)
Acceptance from providers to assess utilization of palliative care services
时间窗: 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.
Resource assessment of staff and space
时间窗: 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.
Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
时间窗: Up to 12 months
Will be assessed using National Comprehensive Cancer Network distress thermometer
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
时间窗: Up to 12 months
Depression assessed using the Hospital Anxiety and Depression Scale
Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)
时间窗: Up to 12 months
Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)
Health care utilization outcomes
时间窗: Up to 12 months
Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events.
Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)
时间窗: Up to 12 months
Ohio State Palliative Care Provider survey used to assess perceived barriers to referral
次要结局
- Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model(Up to 12 months)
研究者
Carolyn Presley
Principal Investigator
Ohio State University Comprehensive Cancer Center