Curative cancer diagnosis with neoadjuvant therapy and tumor surgery ICD10 from C00 to C97 and from D00 to D48
Conditions
Interventions
Group 1: The day-clinic once weekly in person with a multimodal personal prehabilitation group program consists of:
1.) Psychoeducation on stress
2.) Moderated self-help: exchange on naturopathic tre
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.) Patients diagnosed with cancer 2.) Patients planned to undergo or currently undergoing neoadjuvant treatment before intended curative resection 3.) Adult Patients (= 18 years of age) 4.) Written informed consent 5.) Ability to understand character and individual consequences of the clinical trial Additional inclusion criteria for the online program: 6.) Stable internet connection 7.) Laptop or similar 8.) Poultices utensils and utensils for the other applications 9.) Sports mat or similar
Exclusion criteria
Exclusion criteria: 1.) Participation in another interventional trial with interference on intervention and outcome of this trial 2.) Immobility or inability to walk unaided 3.) Expected lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility endpoints 1.) Adherence to the day clinic defined as the ratio of missed appointments during the participation in the program 2.) Patient activation measurement (PAM13) questionnaire at baseline, at the end of neoadjuvant therapy and 1-10 days before surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcome measures: 1.) EORTC QLQ-C30 at baseline, at the end of neoadjuvant therapy and 1-10 days before surgery 2.) Questionnaire on lifestyle: smoking, alcohol, BMI (according to RKI-„Gesundheit in Deutschland” (GEDA)) at baseline, at the end of neoadjuvant therapy and 1-10 days before surgery 3.) Duke Activity Status Index (DASI) at baseline, at the end of neoadjuvant therapy and 1-10 days before surgery 4.) Godin Shepard Leisure Time Physical Activity Questionnaire (GSLTPAQ) at baseline, at the end of neoadjuvant therapy and 1-10 days before surgery 5.) Record whether patients are receiving chemotherapy/radiation treatment at the start of the program and, if so, which cycle they are in 6.) Record - at the final assessment - when the last chemotherapy was and whether there is a next one 7.) Patients’ satisfaction regarding the Day Clinic Program assessed with a non-validated questionnaire 1-10 days before surgery 8.) Written field reports from a voluntary sub-sample at post -operative day (POD) 40 ± 10 Clinician-reported outcome measures: 9.) Hand grip strength using a dynamometer at baseline, at the end of neoadjuvant therapy and 1-10 days before surgery 10.) 30 sec sit to stand (STS) test at baseline and 1-10 days before surgery 11.) One-leg-stance test as long as possible, but maximum 60 sec at baseline and 1-10 days before surgery 12.) BMI at baseline and 1-10 days before surgery | — |
Countries
Germany
Contacts
Public ContactJessica Schwend
Klinik für Allgemein- und Viszeralchirurgie, Fachbereich Integrative Medizin
Outcome results
None listed