Effect of stRess and exeRcize on the Outcome After Chemo-Radiation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of stRess and exeRcize on the Outcome After Chemo-Radiation

Conditions
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Glioblastoma (GBM)

Intervention / Treatment
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* Device: Smartwatch
* Diagnostic Test: Serum Cortisol
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with GBM eligible for Stupp treatment willing to wear the smart watch during the treatment protocol Exclusion Criteria: younger than 18 years not in possession of a smart phone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with glioblastoma treated with STUPP schema<br> | Device: Smartwatch<br>* Patients will wear the smartwatch during treatment which measures, activity, steps, sleep and heartrate<br>Diagnostic Test: Serum Cortisol<br>* Level of cortisol in serum will be determined<br>Other: Questionnaires<br>* Patients are asked to fill in patient reported outcomes (PROMS) and specific questions on stress, exercise and fatigue (QSC-R23, IPAQ-SF, MVI-20)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)? | 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) | 1 year | 
| Is stress a prognostic factor for the progression free- survival at 1 year of patients with glioblastoma (GBM)? | 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) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is stress a prognostic factor for the quality of life of patients with GBM | 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. | 1 year | 
| Is stress a prognostic factor for dose limiting toxicities (CTC) of the treatment? | 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 | 1 year | 
| Is stress a prognostic factor for early termination of the treatment? | 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) | 1 year | 
| Is there a relationship between stress and treatment response measures on MRI imaging | 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, glioblastoma, survival, quality of life