Anxiety, cancer-related fear of progression C50 C51 C52 C53 C54 C55 C56 C57 C58 C81
Conditions
Interventions
Group 1: active intervention with VR mindfulness practice of gynecologic and senologic oncology patients while their chemotherapy (ca. 20 minutes each for two cheomtherapy sessions
The total duration of the trial will vary depending on the interval between chemotherapy sessions)
Group 2: receptive music intervention of gynecologic and senologic oncology patients while their chem
the total duration of the trial will vary depending on the interval between chemotherapy sessions)
Group 3: standard care of gynecologic and senologic oncology patients while their chemotherapy (contr
the total duration of the trial will vary depending on the interval between chemotherapy sessions
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: the presence of a gynecological (C51-55), senological (C50), hematological (C81-85, C91-95) or gastrointestinal cancer (C15ff, C16ff, C18ff, C20ff, C22, C23, C25ff) diagnosis according to ICD-10 Intravenous chemotherapy with an application duration incl. irrigation of at least 60 minutes At least the second chemotherapy session at the time of the intervention Legal capacity Minimum age = 18 years Sufficient knowledge of the German language at least moderate anxiety (>= 5) as measured by the Generalized Anxiety Disorder-7 questionnaire
Exclusion criteria
Exclusion criteria: Severe visual and/or hearing impairment. Neurological/psychiatric pre-existing conditions affecting the vestibular organ, impairing the sense of balance or altering visual perception (e.g., Meniere's disease, dementia, post-stroke condition, psychosis) known epilepsy claustrophobia Severe side effects during the first chemotherapy session (Therefore, study start is planned only from the second session) Chemotherapy in the context of a study wearing cooling gloves or a cooling cap during the chemotherapy sessions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| STAI-State (Staite-Trait-Anxiety Questionnaire, Spielberger et al., 1970), before and after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Physiological sympathetic stress response (heart rate/pulse via pulse oximeter in beats per minutes), HPA axis activity (salivary cortisol), progression anxiety (PA-F-KF; Mehnert et al., 2006), symptom distress (MIDOS-2; Stiel et al., 2010), anxiety via visual analog scale (0=not at all anxious to 100=maximally anxious), satisfaction via visual analog scale (0=not at all satisfied to 100=maximally satisfied), self-efficacy expectancy via General Self-Efficacy Short Scale (ASKU; Beierlein et al., 2014), STAI-Trait (Grimm, 2009), Demographic & disease-related data (adapted from PO Bado, Herschbach et al., 2008), Experiences with mindfulness and music, Usability assessment (7 items from the PSSUQ, Lewis, 1995 & self-created items), Presence of anxiety (Generalized Anxiety Disorder-7 (GAD7) questionnaire, Spitzer et al., 2006), screening for anxiety and depression (Patient Health Questionnaire 4 (PHQ4), Löwe et al., 2010) | — |
Countries
Germany
Contacts
Public ContactSteffen Holsteg
Universitätsklinikum Düsseldorf, Klinisches Institut für Psychosomatische Medizin und Psychotherapie
Outcome results
None listed