A Prospective, Randomized Trial Assessing the Feasibility of an Advance Care Planning Intervention for Patients Hospitalized in a French Cancer Center
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of patients who write advance directives of living at 3 months
研究概览
简要总结
Advanced Cancer patients hospitalized in a Cancer center inpatient unit have a dismal prognosis. Palliative Care interventions have shown multiple benefit for those patients, regarding quality of life, symptom management, illness understanding and aggressiveness of care criteria. Although Advance Care planning (ACP) is part of usual Palliative Care, specific interventions dedicated to ACP are understudied.
This study aims at showing that a simple and systematic Advance Care Planning intervention is likely to clarify the understanding of the goals of care by patients, to help with ACP documentation and and potentially to modify the trajectory of illness for patients during and after hospitalization.
详细描述
PREVOIR is a randomized, single-center, two-arm trial: patients from experimental arm will benefit from a systematic interview on the care plan whereas patients from control arm will received standard cares.
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
- •Patients aged 18 years or older
- •Patients with a diagnosis of advanced or metastatic solid cancer
- •Patients hospitalized in a conventional oncology, radiotherapy or hematology department
- •Agreement obtained from the referring oncologist or senior doctor responsible for the patient during hospitalization
- •Patient hospitalized for less than 7 days
- •Patients who have not yet written advance directives
- •Signature of informed consent
排除标准
- •Patients treated for hematologic malignancies
- •Presence of uncontrolled symptoms that do not allow an interview to be carried out
- •Patients with planned hospitalization for chemotherapy or biopsy or performance of a procedure
- •Patients < 18 years old or patients ≥ 18 years old under supervision
- •Patients placed under judicial protection or guardianship
- •Decompensated neuropsychiatric disorders
- •Comprehension problems
- •Patients without social security
- •Allophone patients
研究组 & 干预措施
Advance Care Planning Intervention
Patients from experimental arm will benefit from a Standardized Advance Care Planning interview alone or in the presence of relatives within 3 days after randomization.
干预措施: Advance Care Planning Intervention (Other)
Standard cares
Patients from control arm will be treated without specific intervention, which does not exclude the possibility of resorting to non standardized advance care planning interviews with an oncologist or a physician specialized in palliative care.
结局指标
主要结局
Percentage of patients who write advance directives of living at 3 months
时间窗: At 3 months from randomization
次要结局
- Percentage of patients who write advance directives of living at 1 month(At 1 month from randomization)
- Overall survival(Up to 6 months)
- Percentage of patients who write advance directives of living at 6 months(At 6 months from randomization)
- Received anti-cancer treatment(up to 6 months)
- Patients living trajectory(up to 6 months)