C15-C26 C67 C61 C50 C54 C56 C53
Conditions
Interventions
Group 1: The day-clinic once weekly multimodal prehabilitation group program consists of:
1.) Naturopathic counselling
2.) Physical exercise program
3.) nutritional optimization
4.) External naturo
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with abdominal cancer (including stomach cancer and extraperitoneal cancers like pancreatic, bladder, rectal, esophageal, endometrial, ovarial and cervical cancer) or breast cancer 2. Patients planned to undergo or currently undergoing neoadjuvant treatment 3. Written informed consent 4. Ability to understand character and individual consequences of the clinical trial
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 |
|---|---|
| 1.Recruitment of a minimum of 8 patients within 3 months. 2.Adherence to the day clinic defined as the ratio of missed appointments during the participation in the program | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) at baseline and once weekly during pre-habilitation 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 at baseline and on POD 4 (or at discharge whatever comes first). 6. The Patient Health Questionnaire depression scale (PHQ-4) 7. Sleep Quality (PSQI) 8. Mindfulness (Five-Facet Mindfulness Questionnaire FFMQ-D) 9. Patients’ satisfaction regarding the Day Clinic Program assessed with a non-validated questionnaire 10. Fatigue (NRS) 11. Qualitative interview Clinician-reported outcome measures 12. Postoperative complications =3 according to Dindo-Clavien 13. Duration of postoperative hospital stay 14. Readmission after initial discharge 15. 6-minute walking test at baseline, end of day clinic 16. Hand grip strength using a dynamometer 17. 1-minute sit to stand test 18. Intensity of analgesic treatment according to the WHO analgesic step ladder 19. BMI at baseline, end of day clinic and on POD 30. 20. Adherence to neoadjuvant treatment during PRIME-DC program | — |
Countries
Germany
Contacts
Public ContactChristian Raff
Universitätsklinikum Ulm Klinik für Allgemein- und Viszeralchirurgie
Outcome results
None listed