Prospective study evaluating the role of Symptom and Distress screening tools in initiating early supportive care in cancer patients treated with curative intent radiation therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To determine mean change in Total ESAS-r score from baseline to RT completion or follow up visit (3 month)
研究概览
简要总结
It is well known that patients diagnosed withcancers experience significant levels of distress. Surveys have shown that20-50% of patients show significant distress.
A landmark randomised studyconcluded that patients with metastatic non–small-cell lungcancer, early palliative care ledto significant improvements in both quality oflife and mood when compared to patients receiving standard care. [1]
Various distress screening tools have been used to objectively detectsignificant levels of distress. The Edmonton Symptom assessment scale has beenwidely used in for many years. [ 2 . 4 , 5 ] The NCCN Distress thermometerscale has also been recently found to be a simple method to identify patientsat high risk for distress. [ 3]
The use of these distress screening tools is expected to help screen andidentify cancer patients with significant psychosocial as well as physicaldistress, so that early initiation of supportive care can be implemented. Thistimely intervention could lead to improvement in well being and quality of lifeof patient.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients diagnosed with non metastatic cancer of any site planned for treatment with radical intent radiation therapy.
排除标准
- •Previous radiation therapy Patients planned for treatment with 10 fractions or less Patients with multiple distant metastases.
结局指标
主要结局
To determine mean change in Total ESAS-r score from baseline to RT completion or follow up visit (3 month)
时间窗: 3 month after RT completion
次要结局
- -To determine the proportion of asymptomatic patients on radiation therapy requiring supportive care based on distress score changes(End of treatment)
- -To determine mean change in QOL scores (FACT- G , TOI scores) from baseline to 1 or 3 months post RT(3 months)
- -To determine most frequent distressing symptom(End of treatment)
- -To determine mean timing of maximum distress from baseline to 6 months post RT(6 months)
- -To determine the mean change in Anxiety & depression score from baseline to 1 / 3 months post RT(3 months)
- -To determine proportion of patients with moderate to severe distress during radiation therapy(End of treatment)
- -To determine the mean change in symptom score because of supportive care using ESAS tool(6 months)