A lifestyle intervention program for patients with localized prostate cancer - a feasibility study
Not Applicable
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00005795
- Lead Sponsor
- niversität Duisburg-EssenLehrstuhl und Klinik für Naturheilkund und Integrative Medizin, Knappschafts-Krankenhaus,Kliniken Essen-Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 17
Inclusion Criteria
• PSA = 10 ng/ml
• Gleason-Score = 6
• cT1c and cT2a
• tumor in = 2 punch biopsies (min. 8 punch biopsies )
• = 50 % tumor / punch biopsy
• life expectancy min. 10 yrs
• Karnofsky-Index min. 80% or ECOG-Performance-Status 0-2
• written informed consent
Exclusion Criteria
• previous or planned partial oder radical prostatectomy
• unsufficient knowledge of German language,
• severe physical or psychological diseases that may constrain patients
• systemic-neurological diseases (MS, parkinson, dementia).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method compliance / adherence during intervention period (diary, attendance time)
- Secondary Outcome Measures
Name Time Method questionnaires:<br>HRQoL (FACT-G, FACT-P)<br>anxiety (STAI)<br>depression (BDI)<br>mindfulness (FFA)<br>stress (PSS)<br>barriers<br>lifestly<br>coping (COPE)<br><br>Other:<br>saliva cortisol<br>pro- and anti-inflammatory cytonkines (plasma)<br><br>all post-intervention (11 weeks)<br><br>