Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner (TOGETHER-study): a Prospective Multicenter Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Progression free survival
研究概览
简要总结
Glioblastoma multiforme (GBM) is the most common malignant central nervous system (CNS) tumor in adulthood with a median survival of 12-16 months. The drastically shorted life expectancy, intellectual changes and rapid physical decline in those patients are devastating and do impose a profound chronic stress on patients and their families. There is extensive evidence that chronic stress can promote cancer growth and progression. In the setting of GBM patients, three major questions still have to be answered and will be analysed in this study:
- Is there a prognostic significance of stress in patients with newly diagnosed GBM on treatment tolerance and (progression free) survival?
- Can this stress be modulated by other factors, like stress of patients partners and patients physical activity, a known independent prognostic factor in recurrent glioma patients?
- How is the longitudinal course of patients and partners stress and physical condition over the disease course and do they influence (progression free) survival?
Answers to these questions will help to establish future projects studying non drug interventions in patients and patients partners to help improving clinical and tumor related outcome in patients with newly diagnosed GBM.
The investigators hypothesize that chronic stress, specifically measured as a disruption of the diurnal cortisol rhythmicity, is an independent prognostic factor in patients with GBM. Furthermore, physical activity of patients and stress level in patients' partners may impact - as stress-modulating factors- on stress in patients and on their prognosis.
Aiming at identifying stress-related prognostic factors as potential targets for novel treatment approaches, we propose, in a first step, a prospective multicenter cohort study: all patients with newly diagnosed GBM and good performance status (KPS ≥ 50%) who undergo standard treatment with combined radiochemotherapy with temozolomide (RCT) followed by 6 month of cyclic temozolomide, are eligible. In addition, one "partner", defined as a close person living in the same home or close daily contact to the patient, will be asked for inclusion.
详细描述
General Aim The aim of this prospective, multicenter observational cohort study is to determine the impact of baseline bio-behavioral stress (Aim I) on cancer progression and survival in patients with newly diagnosed glioblastoma (GBM) undergoing standard radiochemotherapy. The role of baseline physical activity (PA) and baseline partner's distress as stress-modulating factors will be assessed in an exploratory analysis.
Secondary aims include a longitudinal assessment of self-reported psychological distress in this homogenous patient cohort and their partners (Aim II) and -in a translational subproject - to determine the role of serum copeptin as a biomarker for distress (Aim III).
Specific Aims Specific Aim I: Prognostic role of stress at the time of diagnosis in GBM patients In this analysis, baseline neuroendocrine stress will be correlated to progression-free survival (PFS).
More specifically we aim at assessing
IA) Whether stress-induced disruption of diurnal cortisol rhythmicity as measured by the salivary cortisol slope is an independent prognostic factor for (progression-free) survival in patients with newly diagnosed GBM undergoing standard multimodal 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
- •age ≥18 years
- •Karnofsky Performance Score ≥ 50 %
- •histologically confirmed, previously untreated GBM
- •radiochemotherapy according to Stupp et al [1] is planned (ideally, treatment start can be scheduled on a Monday)
- •no cardiovascular or neurological contraindications for 6MWT and/or a history of instable angina pectoris or NYHA grade II or greater congestive heart failure (according to the Thoracic Society recommendations [2])
- •willing and able to comply with the protocol as judged by the investigator
- •signed informed consent
- •age ≥18 years
- •willing and able to comply with the protocol as judged by the investigator
- •spouse or partner living in the same home as the patient or closest contact as named by the patient (1-2h 5 days a week)
- •signed informed consent
排除标准
- •Patients who have any other disease, either metabolic or psychological, or who have any evidence on clinical examination or special investigations (including laboratory findings) which give reasonable suspicion of a condition that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids ≥ 3 months before study entry for disease other than glioblastoma, (dexamethasone use in the context of glioblastoma is allowed)
- •Severe, medically treated psychiatric disorder prior to the diagnosis of glioblastoma
- •Participation in a study with investigational drugs
- •Severe asthma or known allergy against tetracosactide (Synacthen®)
- •Pregnancy or breast feeding
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurologic deficits that interfere with the planned walking tests, dementia or confusional state
- •Individuals who have any disease, either metabolic or psychological, that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids (≥ 3 months), psychiatric disorders)
- •Pregnancy or breast feeding
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state
结局指标
主要结局
Progression free survival
时间窗: 12 month
analysis
次要结局
- Overall survival(12 month)