Effect of stRess and exeRcize on the Outcome After Chemo-Radiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)?
研究概览
简要总结
Glioblastoma (GBM) is a highly malignant, incurable primary brain tumor. Due to the nature of this disease and the extent of the treatment (surgery followed by chemoradiation according to the Stupp trial) patients undergo considerable psychological distress. It is known that stress hormones are involved in a wide range of processes involved in cell survival, cell cycle and immune function, and can cause therapy resistance. In this study the effect of stress on outcome after chemoradiation in patients with GBM will be investigated.
详细描述
Psychological stress will be measured using multiple approaches; Physiological measures, stress biomarker and questionnaires. Using this approach, a broad insight in the relationship between stress and outcome after chemoradiation will be obtained and the potential influence of physical activity and sleep evaluated. In addition, the results of this study will help to identify patients which experience high stress levels during chemoradiation to pilot (in the future) interventions to reduce stress before and during treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients treated with Stupp or Elderly protocol: GBM WHO IV, astrocytoma WHO IV IDHmt, astrocytoma WHO II IDHwt (GBM-like).
- •willing to wear the smart watch during the treatment protocol
排除标准
- •younger than 18 years
- •not in possession of a smart phone
研究组 & 干预措施
patients with glioblastoma treated with STUPP schema
干预措施: Smartwatch (Device)
patients with glioblastoma treated with STUPP schema
干预措施: Serum Cortisol (Diagnostic Test)
patients with glioblastoma treated with STUPP schema
干预措施: Questionnaires (Other)
结局指标
主要结局
Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)?
时间窗: 1 year
Stress variables are heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to overall survival at 1 year (survival = yes/no)
Is stress a prognostic factor for the progression free- survival at 1 year of patients with glioblastoma (GBM)?
时间窗: 1 year
Stress variables are heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to progression free survival at 1 year (progression free survival at 1 year; yes/no)
次要结局
- Is stress a prognostic factor for dose limiting toxicities (CTC) of the treatment?(1 year)
- Is stress a prognostic factor for early termination of the treatment?(1 year)
- Is stress a prognostic factor for the quality of life of patients with GBM(1 year)
- Is there a relationship between stress and treatment response measures on MRI imaging(6 months)