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

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma (GBM)
• Intervention / Treatment: Device: Smartwatch; Diagnostic test: Serum Cortisol; Other: Questionnaires

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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Netherlands
  • Tilburg, Netherlands
    • Verbeeten Insitute Tilburg
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229ET
      • Maastricht Radiation Oncology (Maastro)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a glioblastoma (GBM) eligible for treatment with STUPP or Elderly treatment protocol (concurrent radio-chemotherapy + temozolomide)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Collaborators: Maastricht University Medical Center; Zuyderland Medical Centre; Verbeeten Institute Tilburg
• Investigators: Principal Investigator: Karen Zegers, PhD, Maastro Clinic, The Netherlands

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; survival; stress; glioblastoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: ERROR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No