The effectiveness of nutrition counseling on the nutrition status of patients with gastrointestinal (GI) tumors during and after inpatient medical rehabilitation (reha)
Not Applicable
Recruiting
- Conditions
- C15-C26Malignant neoplasms of digestive organs
- Registration Number
- DRKS00031296
- Lead Sponsor
- CCC München LM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 334
Inclusion Criteria
• Oncology patients with GI tumors on admission to the rehabilitation clinic
• One of the following tumor diagnoses:
esophagus
stomach
colon
pancreas
liver
• Life expectancy = 12 months
Exclusion Criteria
• exclusive artificial nutrition
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method study phase 1: Compared to the control group (CG) 20% more patients in the intervention group (IG) achieve a stabilization/improvement of the nutrition risk status as measured by the Patient generated subjective global assessment - short form (PG-SGA SF) after completion of inpatient medical rehabilitation programms. <br>study phase 2: Compared to the CG 30% more patients in the IG achieve stabilization /improvement of the PG-SGA SF after follow-up nutrition counseling (via telephone) for a period of 6 months.
- Secondary Outcome Measures
Name Time Method • Ability to reintegrate into the workforce (SIBAR screening < 8 in at least 10% more patients in IG)<br>• Reduction of psychological distress (2 point reduction of the distress thermometer in IG)<br>• Improvement of quality of life (improvement of the EQ-5D 5L index value in at least 25% of the patients in IG)<br>• Increase in patient satisfaction with nutrition therapy during medical rehabilitation (positive assessment of nutrition therapy in 50% more patients in IG)