A Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Oncology Care Alone in Patients With Non-colorectal Gastrointestinal Malignancies.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire
研究概览
简要总结
The purpose of this research study is to find out whether it is better to introduce cancer patients to the palliative care team at a later date when there is a specific issue or problem or to introduce cancer patients to the palliative care team when first diagnosed before any specific issue or problem occurs.
详细描述
The investigators will conduct a one-year randomized, controlled study to evaluate the impact of an early, integrated palliative care services. The intervention will include comprehensive palliative care services delivered in conjunction with standard oncology care and patient friendly materials for high risk oncology patients. The investigators primary clinical endpoint will be health related quality of life, specifically focusing on measures of anxiety, depression, and well-being.
Secondary personalized palliative care outcomes are expected to include:
- Reduced deviations from care plan as captured in the medical record compared to the group who did not receive early, integrated palliative care services
- Reduced hospital utilization compared to the group who did not receive early, integrated palliative care services
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •-Adults with newly diagnosed pancreatic, hepatocellular, esophageal, or stomach cancer
- •Upcoming scheduled oncology clinic visit (2nd visit to the clinic) at Vanderbilt
- •Ability to read and respond to questions in English
- •Permission of oncology physician
排除标准
- •-Receiving oncology care at non-Vanderbilt sites (to ensure appropriate follow-up)
- •Participation in another clinical trial
研究组 & 干预措施
Palliative Care + Standard of Care
Consenting patients will be approached by a research nurse to complete quality of life questionnaires (baseline measures) either in the oncology clinics or infusion clinics. Patients assigned to early palliative care will meet with a member of the palliative care team after enrollment and completion of the initial questionnaires to receive and review patient-oriented materials detailing palliative care services. Patients will then receive a comprehensive initial consult with a palliative care provider (a trained physician, nurse or nurse practitioner). Additional consults with the palliative care service will be scheduled approximately every 6 weeks for the duration of the study period (one year) at the discretion of the patient and palliative care provider.
干预措施: Palliative Care (Other)
Standard of Care
Patients will receive standard care from their oncologist. An assessment of health related quality of life will be conducted at regular oncology clinic visits at baseline and 3,6,9,and 12 months.
结局指标
主要结局
Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire
时间窗: 1 year
The FACT Measurement System is a group of questions which measure health-related quality of life (QOL) in cancer patients. The FACT-G is a 26-item version that addresses multiple QOL dimensions including physical well-being, functional well-being, emotional well-being and social well-being. The response format of the FACT Measurement System consists of a 5-point Likert scale.
次要结局
- PROMIS Anxiety Scale(1 year)
- Hospitalizations(1 year)
- PROMIS Depression Scale(1 year)
研究者
Gordon Bernard
Professor of Medicine; Associate Vice-Chancellor for Research
Vanderbilt University