Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not
研究概览
简要总结
The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma.
Participants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.
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
- •Signed written and voluntary informed consent.
- •Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.
- •Age ≥ 18 years.
- •Have not received any previous systemic treatment with palliative intent for advanced sarcoma.
- •Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
- •Life expectancy > 6 months.
- •Willing/able to complete questionnaires.
排除标准
- •Clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion.
- •Patient in need of urgent home support services or symptom management through a palliative care team.
- •Patient is being actively followed by a palliative care physician.
- •Active psychiatric disorder or drug abuse.
- •Insufficient English literacy to complete questionnaires.
研究组 & 干预措施
Standard Treatment
干预措施: Standard Treatment (Other)
Early Referral to Palliative Care
干预措施: Early referral to palliative care (Other)
结局指标
主要结局
To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not
时间窗: From enrollment/baseline to 12 weeks
HRQoL will be assessed using ESAS-r (Edmonton Symptom Assessment System - revised) and EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C-30).
次要结局
未报告次要终点
