The Role of Early Systematic Best Palliative Care Versus on Request Palliative Care Consultation During Standard Oncologic Treatment for Patients With Advanced Gastric or Pancreatic Cancers: a Randomized, Controlled, Multicenter Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 31
- 主要终点
- Quality of Life (QoL)
研究概览
简要总结
Title: The role of early systematic best palliative care versus on request palliative care consultation during standard oncologic treatment for patients with advanced gastric or pancreatic cancers: a randomized, controlled, multicenter trial.
Description of Study Treatment:
- Interventional arm Patients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death. Patients assigned to this experimental arm will be evaluated if the total of palliative care visits between T0 (day of enrollment) and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention has to be oriented by the General guidelines for palliative care: specific attention will be paid to assessing physical and psychosocial symptoms, establishing goals of care, assisting decision making regarding treatment, and coordinating care on the basis of the individual needs of the patients.
The doctor expert in palliative care, with regular visits in the experimental arm, must be a physician dedicated full time to palliative care, that can directly prescribe drugs and other interventions, and with a particular attention to physical, psychological, and spiritual needs.
Palliative care doctor must have the possibility to decide about organizational arrangements.
He has to perform the palliative care visit according to Temel indications. 2. Standard arm Patients will receive standard oncologic care and will be assigned to on request palliative care consultation. They will be not scheduled to meet with the palliative care service unless a meeting will be requested by the patients, the family, or the oncologist. After the time of evaluation (T1) patients will be followed by the palliative care services as needed.
Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks ± 3.
Patients will receive standard antineoplastic treatment in both arms of the study according to best clinical practice in each participating centre.
详细描述
Title: The role of early systematic best palliative care versus on request palliative care consultation during standard oncologic treatment for patients with advanced gastric or pancreatic cancers: a randomized, controlled, multicenter trial.
Short Title/Acronym: Early palliative care
Protocol Code: IRST 100.08
Study Design: randomized, controlled, multicenter trial
Study Duration: 2 years
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
- •diagnosis of inoperable locally advanced and/or metastatic gastric or pancreatic cancers within the previous eight weeks, any T, any N, M+ or T4 inoperable (neoadjuvant excluded);
- •patients eligible for chemotherapy and/or new target drugs treatments for metastatic or advanced disease;
- •ECOG PS 0-2 (Appendix A);
- •life expectancy >2 months;
- •age ≥18 years;
- •all ethnic background;
- •subjects who are, in the opinion of the Investigator, able to understand this study and to cooperate with the study procedures;
- •written informed consent (Appendix B);
- •palliative care visit must be performed by a dedicated physician/team different from the medical oncology group.
排除标准
- •patients already receiving care from the palliative care service;
- •prior chemotherapy and/or new target drugs treatments for metastatic or advanced disease.
研究组 & 干预措施
Interventional arm
Interventional arm
干预措施: Interventional arm: Early best palliative care (Other)
Standard arm
Standard arm
结局指标
主要结局
Quality of Life (QoL)
时间窗: 24 months
It is the change in the score from T0 (day of enrollment) to T1 (12±3 weeks) on the Trial Outcome Index (TOI) \[which is the sum of the scores of specific subscale FACT-Ga or FACT-Hep Functional Assessment of Cancer Therapy-Gastric cancer (FACT-Ga) and Functional Assessment of Cancer Therapy-Hepatobiliary cancers (FACT-Hep) scales, concerning physical symptoms, physical and functional well being\].
次要结局
- Impact of families satisfaction(24 months)
- Overall survival (OS)(24 months)
- Hospital Anxiety and Depression Scale (HADS)(24 months)