YINOTA-ORecruiting

Effectiveness of Online Yoga Therapy for Patients with Brain Tumors and Their Family Members

Gender
Women and men
Age
18 years and older
Trial type
Interventional
Line of therapy
all
Phase
Phase II

What is this trial about?

Malignant brain tumors place a heavy burden on patients and their families and can cause symptoms of depression and anxiety. Regular yoga sessions can be used as a supportive measure and may improve quality of life for those affected. The goal of the YINOTA-O study is to investigate the effects of an online yoga program on patients’ emotional distress, quality of life, and stress-related physiological risk factors. Women and men aged 18 and older who have a high-grade brain tumor or who are family members of such patients are eligible to participate in this study.

Trial flow

Requirements

Diagnosis: Brain tumour

Age: 18 years and older

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: WHO grade 3-4; at least 6 weeks after surgery

Allocation

Randomisierung

Treatment

approx. 21 weeks
online yoga programmequestionnaire set and an appointment for blood and hair sampling. The intervention group begins the 8-week yoga intervention immediately. At the end of the 8-week yoga intervention and again 3 months later, participants receive another questionnaire set and an appointment for blood and hair sampling.
Waiting time (no intervention)questionnaire set and an appointment for blood and hair sampling. Participants are then randomly assigned to an intervention group or an 8-week waiting control group. The waiting control group receives standard medical care and, if necessary, therapeutic and supportive care. At the end of the intervention group's yoga course, participants in the waiting control group will also receive another questionnaire set and an appointment for blood and hair sampling. The waiting control group will then receive the same intervention. At the end of the 8-week intervention for the waiting control group and 3 months later, participants will again receive questionnaire sets and appointments for blood and hair sampling.

Follow-up

5 months

Detailed description

Brain tumors are neoplastic diseases of the central nervous system in which cells in the brain or spinal cord grow uncontrollably. Depending on the cell type, they are classified into various subgroups, such as astrocytomas, oligodendrogliomas, glioblastomas, ependymomas, or meningiomas. In addition, they are classified into so-called grades according to the WHO classification: Malignant tumors that grow rapidly and have a poorer prognosis are assigned to Grade 3 or Grade 4. Treatment is tailored individually to each patient. It may include surgery, radiation therapy, chemotherapy, targeted therapy, or immunotherapy. Brain tumors can cause, among other things, headaches, neurological deficits, seizures, and changes in personality. In addition, patients may exhibit symptoms of depression and anxiety. Studies conducted to date suggest that yoga can alleviate the severity of anxiety and depressive symptoms in patients with cancer. However, these studies were not conducted specifically for patients with brain tumors. Furthermore, there have been very few studies to date that examine the supportive potential of yoga for family members of brain tumor patients.

The aim of this Phase 2 study is to investigate the effects of an online yoga program on emotional distress, quality of life, and stress-related physiological risk factors in patients and their family members. As part of the study, patients and their family members will be randomly assigned to two groups. The intervention group will receive an 8-week online yoga intervention (1 hour per week). The control group will continue to receive medical and supportive care but will not receive the yoga intervention. Immediately before and after the intervention, as well as 3 months after the intervention ends, the patients and their family members will complete several standardized questionnaires. The primary endpoint of the study is the level of perceived anxiety when comparing the two groups. Since psychological stress can also affect the body, blood and hair samples from the participants will also be analyzed.

Women and men aged 18 and older who have a high-grade brain tumor, or who are family members of such patients, are eligible to participate in this study. Participants must not have any severe neurological impairments that would preclude participation in a yoga class.

Facts

  1. What condition: Brain tumor
  2. Cancer characteristics: WHO grade 3 or 4, initial diagnosis or recurrence, at least 6 weeks after surgery
  3. What the study investigates: Effects of an online yoga program on emotional distress, quality of life, and stress-related physiological parameters (in blood and hair samples)
  4. Study objective: To examine whether participating in the yoga sessions can improve quality of life and reduce the level of anxiety experienced by patients and their family members
  5. Study duration: approx. 5 months (8-week intervention + questionnaires 3 months after completion)
  6. Study characteristics: Phase 2, randomized, open-label, with an intervention and a control group

Trial sites

6 trial sites in Germany are listed.

  • Klinikum Aschaffenburg-Alzenau gemeinnützige GmbH

    Am Hasenkopf 1, 63739 Aschaffenburg

    Status unknown
  • Universitätsklinikum Augsburg

    Stenglinstraße 2, 86156 Augsburg

    Recruiting
  • Medizinische Hochschule Hannover

    Carl-Neuberg-Str. 1, 30625 Hannover

    In preparation
  • Universitätsklinikum Mannheim Gmbh

    Theodor-Kutzer-Ufer 1-3, 68167 Mannheim

    Status unknown
  • Comprehensive Cancer Center Mainfranken

    Würzburg

    Status unknown
  • Universitätsklinikum Würzburg

    Josef-Schneider-Str. 6, 97080 Würzburg

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.