NCT07190755招募中不适用
Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Curative Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC) With Radiotherapy or Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Impact of remote monitoring of symptoms on weight loss
研究概览
简要总结
The use of digital strategies to systematically monitor patients' symptoms in clinical settings allows problems to be detected at an early stage before they worsen or lead to complications. In this study, the hypothesis is that the proportion of patients with a weight loss of at least 5% between before radiotherapy/radiochemotherapy and 3 months after treatment would be lower with optimised care thanks to remote monitoring using a medical telemonitoring solution in oncology.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged over 18 and under 75 years WHO score < 2,
- •Treated for localised heand and neck cancer of the squamous cell carcinoma type for which curative treatment has been chosen and receiving radiotherapy or radio-chemotherapy exclusively or as an adjuvant with the aim of cure
- •Having signed the informed consent form,
- •Affiliated with or beneficiary of a social protection scheme,
- •Access to a smartphone or the internet,
排除标准
- •History of other neoplastic disease less than 2 years ago or progressive disease,
- •History of ENT radiotherapy,
- •Pregnant or breastfeeding women,
- •Protected adults (under guardianship, curatorship or judicial protection),
- •Patients participating in a therapeutic study,
- •Patients unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological or geographical issues, etc.), patients with blindness preventing the use of the medical telemonitoring solution in oncology.
结局指标
主要结局
Impact of remote monitoring of symptoms on weight loss
时间窗: 3 months after treatment
Proportion of patients with at least a 5% reduction in weight 3 months after treatment compared to the consultation at the start of radiotherapy or radiochemotherapy
次要结局
- Impact of remote symptoms monitoring on global survival(18 month after treatment)
研究者
研究点 (2)
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