Glioblastoma (GBM)
Conditions
Keywords
stress, glioblastoma, survival, quality of life
Brief summary
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.
Detailed description
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.
Interventions
DEVICESmartwatch
Patients will wear the smartwatch during treatment which measures, activity, steps, sleep and heartrate
DIAGNOSTIC_TESTSerum Cortisol
Level of cortisol in serum will be determined
OTHERQuestionnaires
Patients are asked to fill in patient reported outcomes (PROMS) and specific questions on stress, exercise and fatigue (QSC-R23, IPAQ-SF, MVI-20)
Sponsors
Maastricht Radiation Oncology
Maastricht University Medical Center
Zuyderland Medical Centre
Verbeeten Institute Tilburg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* younger than 18 years * not in possession of a smart phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)? | 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)? | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Is stress a prognostic factor for the quality of life of patients with GBM | 1 year | Stress variables like heartrate, sleep, serum cortisol and the Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to quality of life (EuroQol 5D) EuroQol 5D: The 5 questions on the health condition will be scored on a 3-point scale (1-3) By placing these numbers after each other a 5-digit index will occur which provides the health profile. This 5-digit number can be re-calculated to a total score. |
| Is stress a prognostic factor for dose limiting toxicities (CTC) of the treatment? | 1 year | Stress variables like heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to EORTC Common Toxicity Criteria (CTC) score. CTC: ranging from grade 1: mild to 5: death |
| Is stress a prognostic factor for early termination of the treatment? | 1 year | Stress variables like heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to early treatment cessation. early treatment cessation (yes/no) |
| Is there a relationship between stress and treatment response measures on MRI imaging | 6 months | Stress variables like heartrate (min, max, average), sleep (duration, interruptions), serum cortisol and Questionnaire on Stress in Cancer Patients revised version (QSC-23) are related to potential changes in clinical MRI (clinical significant edema and/or clinical significant radionecrosis) Potential changes in clinical MRI (yes/no) |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORKaren Zegers, PhD
Maastro Clinic, The Netherlands
Outcome results
None listed