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

Maastricht Radiation Oncology42 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Glioblastoma (GBM)

Interventions

SmartwatchDEVICE

Patients will wear the smartwatch during treatment which measures, activity, steps, sleep and heartrate

Serum CortisolDIAGNOSTIC_TEST

Level of cortisol in serum will be determined

QuestionnairesOTHER

Patients are asked to fill in patient reported outcomes (PROMS) and specific questions on stress, exercise and fatigue (QSC-R23, IPAQ-SF, MVI-20)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Maastricht Radiation Oncology (Maastro)

Maastricht, Limburg, Netherlands

Verbeeten Insitute Tilburg

Tilburg, Netherlands

Outcomes

Primary Outcomes

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)

Time frame: 1 year

Is stress a prognostic factor for the progression free- survival at 1 year of patients with glioblastoma (GBM)?

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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