Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 4
- 主要终点
- 34 items - Supportive Care Needs Survey
研究概览
简要总结
The study main objective is to assess whether the early introduction of supportive care demonstrates a benefit on patients' psychological care needs at 6 months (M6), versus oncological standard of care in patients with metastatic UM.
Supportive care in patients with metastatic Uveal Melanoma (UM)
详细描述
Before the start of the study, medical oncologists and supportive care physicians from both the sites will attend Communication Skills Training (CST) workshops provided by an expert team in the field. The training sessions will focus on practicing the required communication skills needed in consultations.
The randomization will assign patients, with a 1:2 ratio, to "Introduction of supportive care when medically needed" (Arm A: Control Group) or "Initial concomitant management by the oncologist and the supportive care team" (Arm B: Early Together Group).
Selected and validated questionnaires will be filled at baseline, 6 and 12 months by the patients before the consultation, in the 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •adult patients with metastatic UM;
- •no surgery or loco-regional treatment of metastases in a curative intent;
- •systemic treatment planned or started since less than 2 months;
- •ECOG PS 0-1;
- •no uncontrolled symptoms;
- •liver function tests in normal range or ≤ grade 2;
- •signed informed consent;
- •able to fill the questionnaires.
排除标准
- •patient<18 years old;
- •patient condition requiring supportive care before any systemic specific treatment for metastases;
- •acute psychopathological disorder incompatible with the study;
- •prior medical condition incompatible with the study.
结局指标
主要结局
34 items - Supportive Care Needs Survey
时间窗: 6 months
The main study criterion is the score to the "Care and Support Needs" domain (items 18-22) of the SCNS-SF34 questionnaire obtained in the two arms at 6 months after inclusion. A 10 points mean score difference expected between groups. Each question is ranged from 0 (no need of supportive care) to 5 (strong need of supportive care). Scores for Outcome 1 may vary from 0 to 25.
次要结局
未报告次要终点