Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner (TOGETHER)
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|ClinicalTrials.gov Identifier: NCT02129335|
Recruitment Status : Terminated (insufficient enrollment)
First Posted : May 2, 2014
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Neoplasms Glioblastoma||Other: stress|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner (TOGETHER-study): a Prospective Multicenter Cohort Study.|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||May 2017|
patient with glioblastoma diagnosis and partners
stress level and survival
- Progression free survival [ Time Frame: 12 month ]analysis
- Overall survival [ Time Frame: 12 month ]analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129335
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Luzern, Switzerland, 6000|
|University Hospital Neurology|
|Zürich, Switzerland, 8091|
|Study Chair:||Viviane Hess, MD||University Hospital, Basel, Switzerland|
|Principal Investigator:||Katrin Conen, MD||University Hospital, Basel, Switzerland|