patients with metastasied tumor diseases (bone or brain metastases) during 2 week inpatient palliative radiotherapy (bone or brain radiation)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Minor fatigue according to MFI (Multidimensional Fatigue Inventory) life expactancy > 3 month Karnofsky Index >= 60 indication for palliative whole brain irradiation or bone irradiation writen consent in study participation and data handling
Exclusion criteria
Exclusion criteria: Major psychiatric (pre-)condition; known allergy against used substances; medical conditions that can cause fatigue, such as untreated hypothyreosis, sleeping apnoe, insomnia, anemia with Hb<8 g/dl, cachexia with BMI< 20, chronic renal failure, acute depression; other indispositions, skin conditions and medical conditions that can compromise the treatment according to study protocol; participation in other trials when interfering with this study; multiple liver metastasis (could cause pain during the application)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue; Multidimensional Fatigue Inventory – German version (MFI) (Schwarz, Krauss, & Hinz, 2003; Smets, Garssen, Bonke, & De Haes, 1995); time of measurement: before intervention, after intervention period and follow up two weeks after end of intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| Health related QoL; European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30) (Aaronson et al., 1993). psychosocial distress; NCCN Distress-Thermometer, German version (Mehnert, Müller, Lehmann, & Koch, 2006). time of measurement: before intervention, after intervention period and follow up two weeks after end of intervention period. Physiological outcomes: - heart rate variability (HRV), time of measurement: before intervention, after intervention period - body core temperature, measured before and after every single application Qualitative analysis of the intervention: - visual analog scales (VAS) for mood, relaxation, fatigue; measured before and after every single application - problem centered interviews to capture the patientens perspective on the intervention; at the end of the two week intervention period. | — |
Countries
Germany
Contacts
Charité Universitätsmedizin