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| Name | Class |
|---|---|
| Maastricht University Medical Center | OTHER |
| Zuyderland Medical Centre | OTHER |
| Verbeeten Institute Tilburg | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with glioblastoma treated with STUPP schema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartwatch | Device | Patients will wear the smartwatch during treatment which measures, activity, steps, sleep and heartrate |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a glioblastoma (GBM) eligible for treatment with STUPP or Elderly treatment protocol (concurrent radio-chemotherapy + temozolomide)
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| Name | Affiliation | Role |
|---|---|---|
| Karen Zegers, PhD | Maastro Clinic, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht Radiation Oncology (Maastro) | Maastricht | Limburg | 6229ET | Netherlands | ||
| Verbeeten Insitute Tilburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19269895 | Background | Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9. | |
| 11180574 |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Serum Cortisol | Diagnostic Test | Level of cortisol in serum will be determined |
|
| Questionnaires | Other | Patients are asked to fill in patient reported outcomes (PROMS) and specific questions on stress, exercise and fatigue (QSC-R23, IPAQ-SF, MVI-20) |
|
| 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 |
| Tilburg |
| Netherlands |
| Background |
| Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6. |
| 12627260 | Background | Sehlen S, Hollenhorst H, Schymura B, Herschbach P, Aydemir U, Firsching M, Duhmke E. Psychosocial stress in cancer patients during and after radiotherapy. Strahlenther Onkol. 2003 Mar;179(3):175-80. doi: 10.1007/s00066-003-1018-z. |
| 28956223 | Background | Kelly C, Majewska P, Ioannidis S, Raza MH, Williams M. Estimating progression-free survival in patients with glioblastoma using routinely collected data. J Neurooncol. 2017 Dec;135(3):621-627. doi: 10.1007/s11060-017-2619-1. Epub 2017 Sep 27. |
| 18087223 | Background | Mattern J, Buchler MW, Herr I. Cell cycle arrest by glucocorticoids may protect normal tissue and solid tumors from cancer therapy. Cancer Biol Ther. 2007 Sep;6(9):1345-54. doi: 10.4161/cbt.6.9.4765. Epub 2007 Jul 19. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |