Effect of stRess and exeRcize on the Outcome After Chemo-Radiation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)?
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
patients with glioblastoma treated with STUPP schema
Intervention: Smartwatch (Device)
patients with glioblastoma treated with STUPP schema
Intervention: Serum Cortisol (Diagnostic Test)
patients with glioblastoma treated with STUPP schema
Intervention: Questionnaires (Other)
Outcomes
Primary Outcomes
Is stress a prognostic factor for the overall survival of patients with glioblastoma (GBM)?
Time Frame: 1 year
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)
Is stress a prognostic factor for the progression free- survival at 1 year of patients with glioblastoma (GBM)?
Time Frame: 1 year
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)
Secondary Outcomes
- Is stress a prognostic factor for dose limiting toxicities (CTC) of the treatment?(1 year)
- Is stress a prognostic factor for early termination of the treatment?(1 year)
- Is stress a prognostic factor for the quality of life of patients with GBM(1 year)
- Is there a relationship between stress and treatment response measures on MRI imaging(6 months)