Effect of StRess and ExeRcize on the Outcome After Chemo-Radiation (ERROR)

Maastricht Radiation Oncology

Status: Enrolling

Conditions: Glioblastoma (GBM)

Treatments: Device: Smartwatch; Other: Questionnaires; Diagnostic Test: Serum Cortisol

Study type: Observational

Funder types: Other

Identifiers

NCT05431348

ERROR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

patients with glioblastoma treated with STUPP schema

Treatment:

Diagnostic Test: Serum Cortisol

Other: Questionnaires

Device: Smartwatch