C15 C16 C17 C18 C19 C20 C21 C22 C23 C25 C67 C61 C50 C54 C56 C53
Conditions
Interventions
Group 1: Day-clinic once weekly multimodal prehabilitation group program consisting of:
1.) a standardized Mind-Body-Medicine Intervention
2.) a physical exercise program
3.) nutritional optimization
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with intracavity cancer (including extraperitoneal cancers like prostata, bladder, rectal or esophageal cancer) and breast cancer 2. Patients planned to undergo or undergoing neoadjuvant treatment 3. Planned potentially curative oncological setting 4. Adult Patients (= 18 years of age) 5. Written informed consent 6. Ability to understand character and individual consequences of the clinical trial 7. Investigator considers patient suitable for day clinic program
Exclusion criteria
Exclusion criteria: 1. Participation in another interventional trial with interference on intervention and outcome of this trial 2. American Society of Anesthesiologists (ASA) grade >3 3. Immobility or inability to walk unaided 4. Expected lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility endpoints: 1. Recruitment of a minimum of 8 patients within 3 months. 2. Compliance defined as 80% of participants attending a minimum of 7 out of 11 day clinic sessions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcome measures: 3. EORTC QLQ-C30 4. A core set of 13 cancer-associated symptoms (fatigue, insomnia, pain, shortness of breath, cognitive problems, anxiety, loss of appetite, nausea, vomiting, depression, neuropathy, constipation, diarrhea) with the Patient-Reported Out-comes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) 5. Quality of recovery according to QoR-15 6. The Patient Health Questionnaire depression scale (PHQ-4 7. Sleep Quality (PSQI) 8. Mindfulness (Five-Facet Mindfulness Questionnaire FFMQ-D)/ISBF 9. Patients’ satisfaction regarding the Day Clinic Program 10. Fatigue (NRS) Clinician-reported outcome measures: 11. Postoperative complications =3 according to Dindo-Clavien within 30 days after the index operation 12. Duration of postoperative hospital stay 13. Readmission after initial discharge from the index operation within 30 days 14. 6-minute walking test 15. Hand grip strength using a dynamometer 16. 1-minute sit to stand test 17. Intensity of analgesic treatment according to the WHO analgesic step ladder (0, Step 1, Step 2, Step 3) 18. BMI at baseline, end of day clinic and on POD 30. 19. Adherence to neoadjuvant treatment | — |
Countries
Germany
Contacts
Public ContactChristian Raff
Klinik für Allgemein- und Viszeralchirurgie, Fachbereich Integrative Medizin
Outcome results
None listed