Individual home training for patients with head and neck tumors - a multi-centre study to improve the quality of life (HeiKo study) - OSHO #94
- Conditions
- Head-neck Tumors
- Registration Number
- DRKS00023883
- Lead Sponsor
- Klinik III (Hämatologie, Onkologie, Palliativmedizin) Zentrum für Innere Medizin Universitätsmedizin Rostock
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 53
Patients with tumours of mouth, jaw, face and neck (ICD: C00-C14, C30-C32) in follow-up (following antineoplastic therapy) or stable remission under immunotherapy
- medical authorisation
Patients who meet at least one of the following criteria are not included in this study:
- non-consenting patients
- not all inclusion criteria are met
- clinically relevant heart failure (NYHA III and IV),
- fresh myocardial infarction (< 4 weeks),
- unstable angina pectoris,
- higher-grade valve vitias (with a history),
- uncontrolled cardiac arrhythmias,
- chronic obstructive pulmonary disease, disease stage III or higher according to GOLD,
- paVK from stage III to Fontaine
- diseases that could seriously impair cognitive performance (e. g. dementia, stroke, Wernicke-Korsakoff syndrome)
- < 24 points Mini-Mental State Examination (MMSE)
- known alcohol dependence
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase A - Feasibility (N=25, completed)<br>Percentage of patients who perform the training intervention in a home-based setting over 12 weeks<br><br>Phase B - Quality of life (N=53, recruiting)<br>Change of the global QoL score (EORTC-QLQ-30) after a 12-week training intervention in the home-based setting
- Secondary Outcome Measures
Name Time Method