A Randomized Comparative Prospective Multicenter Study of the Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- Aggressiveness of care near the end of life
研究概览
简要总结
This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers.
In the standard arm, patients will be managed regardless of their PALLIA-10 score, following conventional strategy. In the experimental arm, patients will be systematically referred to a palliative care team.
详细描述
This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers.
All patients undergoing a visit in the daily emergency room of a participating center and who need for palliative management (PALLIA 10 score > 3/10) will be considered for inclusion in the PALLU study. After signing the written informed consent, patients will be randomized (1:1 ratio) in one of the following arms:
- Standard arm : conventional strategy; patients will be managed regardless of their PALLIA-10 score. The need for additional care, including palliative care, will be assessed by the team in charge of the patient, as per routine practice.
- Experimental arm : experimental strategy; patients will be systematically referred to a palliative care team.
Randomization will be stratified according to the investigation center and pre-existing follow-up by pain management team.
The difference of intervention will lie in the fact that patients will be referred or not to a palliative care team but patients from the standard arm may receive palliative care as deemed necessary by the medical oncology team. In this case, the content of palliative care for patients included in both groups will be identical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male or female ≥ 18 years at the day of consenting to the study;
- •Confirmed diagnosis of any type of solid or haematology tumours, with or without Current oncological treatment, such as chemotherapy, immunotherapy, targeted therapy, etc;
- •Unscheduled admission in a French Regional Comprehensive Anti-Cancer Centre due to an acute, unpredictable, intercurrent event related to cancer, its therapies or a comorbidity;
- •Patient for whom disease is considered as not curable;
- •PALLIA-10 Score > 3/10;
- •Willingness and ability to comply with the study requirements;
- •Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrolment;
- •Patient must be covered by a medical insurance.
排除标准
- •Patient without consciousness, unable to provide a written informed consent (context of emergency);
- •Patient treated with a curative intent;
- •Previous randomization in this clinical study;
- •Patients already followed-up by a palliative care team;
- •Life expectancy shorter than 1 month, as per the emergency units' staff judgement.
- •Any medical or psychosocial condition that would compromise the patient's compliance to the study visits or would likely interfere with the completion of Patient-Reported Outcomes.
- •Patients under tutorship or curatorship.
研究组 & 干预措施
Standard
Conventional strategy: patients will be managed regardless of their PALLIA-10 score. The need for additional care, including palliative care, will be assessed by the team in charge of the patient, as per routine practice.
Experimental
Experimental strategy: patients will be systematically referred to a palliative care team.
干预措施: Systematic referral to a palliative care team (Other)
结局指标
主要结局
Aggressiveness of care near the end of life
时间窗: From date of randomization until the date of death from any cause, assessed up to 30 months
Percentage and number of patients who meet at least one of the following criteria : * More than 1 hospitalization in the last 30 days of life; * More than 1 visit in an emergency unit in the last 30 days of life; * More than 14 days in hospital in the last 30 days of life; * Hospitalization in a resuscitation unit in the last 30 days of life; * Treatment with systemic anticancer therapy in the last 14 days of life; * New systemic anticancer therapy regimen starting in the last 30 days of life; * Patients dying in an acute care setting.
次要结局
- More than 1 hospitalization in the last 30 days of life(From date of randomization until the date of death from any cause, assessed up to 48 months)
- Death in an acute care setting(At the date of death from any cause, assessed up to 30 months)
- Medical resources mobilized in terms of palliative care(From date of randomization until the date of death from any cause, assessed up to 30 months)
- Health-related quality of life using the HADS(At inclusion, 3 months, 6 months, 9 months and at 12 months)
- Hospitalization in a resuscitation unit in the last 30 days of life(From date of randomization until the date of death from any cause, assessed up to 30 months)
- Treatment with chemotherapy in the last 14 days of life(From date of randomization until the date of death from any cause, assessed up to 30 months)
- New chemotherapy regimen starting in the last 30 days of life(From date of randomization until the date of death from any cause, assessed up to 30 months)
- Health-related quality of life using the FACT-G7 cancer specific questionnaire(At inclusion, 3 months, 6 months, 9 months and at 12 months)
- Place of death(At the date of death from any cause, assessed up to 30 months)
- More than 1 visit in an emergency unit in the last 30 days of life(From date of randomization until the date of death from any cause, assessed up to 30 months)
- More than 14 days in hospital in the last 30 days of life(From date of randomization until the date of death from any cause, assessed up to 30 months)
- Overall Survival(At the date of death from any cause, assessed up to 30 months)
- Symptoms of cancer disease using the Edmonton Symptoms Assessment System (ESAS) symptom scores(From date of randomization until the date of death from any cause, assessed up to 30 months)