Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner
NCT02129335 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12
Last updated 2017-05-17
Summary
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:
1. Is there a prognostic significance of stress in patients with newly diagnosed GBM on treatment tolerance and (progression free) survival?
2. 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?
3. 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.
Conditions
- Neoplasms
- Glioblastoma
Interventions
- OTHER
-
stress
stress level and survival
Sponsors & Collaborators
-
University Hospital, Zürich
collaborator OTHER -
Luzerner Kantonsspital
collaborator OTHER -
Insel Gruppe AG, University Hospital Bern
collaborator OTHER -
University Hospital, Basel, Switzerland
lead OTHER
Principal Investigators
-
Viviane Hess, MD · University Hospital, Basel, Switzerland
-
Katrin Conen, MD · University Hospital, Basel, Switzerland
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2016-10-31
- Completion
- 2017-05-31
Countries
- Switzerland
Study Locations
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