Efficacy of an online yoga-intervention in patients with a brain-derived tumor of WHO grades 3 & 4 and their caregivers.

Phase 2

Conditions: C71.9
Brain, unspecified

Registration Number: DRKS00029554

Lead Sponsor: niversitätsklinikum Würzburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 140

Inclusion Criteria

Diagnoses: disease of a brain-derived tumor WHO grades 3 & 4 (initial diagnosis and/or recurrent disease; 6 weeks after surgery at the earliest) (applies to patients only); Caregivers of a patient with a brain-derived tumor (WHO grades 3 & 4).
Age = 18 years; regular access to a computer with internet access.

Exclusion Criteria

Insufficient German language skills; severe cognitive, affective or physical limitations

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the level of anxiety measured with the questionnaire for generalized anxiety disorder (GAD-7) before the start and after the end of the intervention as well as 3 months later. The primary endpoint is reached if the level of anxiety in the intervention group is significantly lower than in the waiting-list control group after the end of the intervention.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include progression anxiety (PA-F-KF), depression (PHQ-9), quality of life (EORTC QLQ-C30 + BN 20), BDNF, DHEA/DHEAS, ferritin, and hair cortisol. <br><br>In addition, potential confounding factors are recorded: Sociodemographic data, general health data (patient only: type and stage of disease, time of diagnosis, treatment), current health data (patient only: current treatment and possible current changes in the course of the disease). <br><br>All parameters (except sociodemographic data and general health data) will be collected before and after the intervention and 3 months after the end of the intervention. <br><br><br>Sociodemographic data will be asked once at the first time point of the study and general health data will be taken from the electronic patient record at this time point of measurement by study staff.