Early Palliative Care and Hematological Cancer Patients: a Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Adherence to the palliative care program assessed by percentage of patients attending palliative care visits after 3 months from the enrolment
研究概览
简要总结
The aim of the study is to pilot and evaluate a new integration model between a Specialised Palliative Care (SPC) intervention and standard hematological care in an Italian hospital. This is a feasibility mix-methods study, where a sample of advanced hematological patients are randomised to receive integrated hematological care and a SPC intervention or standard hematological care throughout the course of the predictive last active treatment.
详细描述
The most recent World Health Organization (WHO) definition of palliative care advocates that palliative care principles "...should be applied as early as possible in the course of any chronic, ultimately fatal illness". The difference with the previous WHO vision was substantial, as the earlier definition recommended Palliative Care to patients not responsive to curative therapy, limiting its role to the last period of life.
Evidence about the effectiveness of an early integration of palliative care has begun to emerge in the last years, primarily for cancer patients. The results of experimental studies, showed the effectiveness of early integration of palliative in the management of advanced illness, in improving quality of life, reducing consumption of resources, and possibly increasing survival. These data were also confirmed in Italy.
Hematological advanced patients suffer from a very high symptoms burden, psychological, spiritual, social and physical symptoms. They are very similar to oncological advanced patients. Hematologic patients during the last 30 days of their life are more frequently admitted in Hospital setting, emergency departments and high care ward than oncological patients, they received more aggressive treatments and more chemotherapy or biologic active treatments than oncologic patients.
Looking to WHO's palliative care definition and hematologic patients' symptoms burden it's simple to imagine that an early access to palliative care service could be the answer, as it was for advanced oncologic patients. The rational of the new vision lied on the recognition that palliative care had the potential to improve quality of life of patients and their family members during the whole trajectory of an incurable disease, through an effective management of psychological and physical symptoms, appropriate relationships, effective communication and support in decision-making.
In addition, even if WHO definition is referred to incurable patients, recent experience on Palliative care and Hematology is also about potentially curative patients.
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
盲法说明
centralized randomization
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
- •Histologically or cytologically confirmed incurable hematological tumor;
- •Estimated prognosis by the hematologist more than 1 month at least;
- •Predictive last active treatment (chemotherapy or immunotherapy) as established by hematological team;
- •18 years old;
- •Eastern Cooperative Oncology Group ≤ 3;
- •Ability to read and respond to questions in Italian;
- •Consent to the study
排除标准
- •Existence of other co morbid disease which in the opinion of the investigator prohibits participation in the protocol;
- •Caregiver's absence
结局指标
主要结局
Adherence to the palliative care program assessed by percentage of patients attending palliative care visits after 3 months from the enrolment
时间窗: 3 months after the enrollment
the investigators consecutively register all eligible patients (and reasons for ineligibility) both from Hematological department, patients who were asked to participate to the study (and reasons for not), patients who accepted to participate (and reasons for not). The feasibility will be achieved if \>50% of patients remain in the program in the next 3 months from the enrollment
次要结局
- incidence of anxiety and depression between patients enrolled(At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months)
- quality of life of patients assessed by symptoms control 'measurement(At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months)
- Performance status changing during the program(At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months)
- Qualitative evaluation by patients/caregivers on palliative care program(After 12 weeks from the randomization for patients or caregivers. Investigators establish as necessary that patients have attended 3 palliative care visits. Professionals will be interview at the end of the enrolment)
- Quality of life of patients assessed by Palliative Care Outcomes Scale(At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months)