KORE-Innovation: a Prospective, Multi-site Clinical Trial to Implement and Analyse the Effects of an Innovative Perioperative Care Pathway to Reduce Complications for Patients With Ovarian Cancer (KORE)
Ovary Cancer, Fallopian Tube Cancer, Peritoneum Cancer
About this trial
This is an interventional health services research trial for Ovary Cancer focused on measuring Perioperative care, Prehabilitation, Enhanced Recovery after Surgery, Patient Empowerment, Postoperative Complications
Eligibility Criteria
Inclusion Criteria:
- Women with primary diagnosis of ovarian, fallopian tube or peritoneal cancer and primary surgical treatment (all histological subgtypes, all FIGO-stages)
- women with first recurrence of ovarian, fallopian tube or peritoneal cancer and primary surgical treatment (all histological subgtypes, all FIGO-stages)
- patients who have given and signed informed consent-forms
Exclusion Criteria:
- inoperable situs
- neoadjuvant chemotherapy
- simultaneous diagnosis of secondary primary tumors (except for breast cancer)
- dementia or other psychological diseases, that impair comprehence and compliance
- pregnancy
Sites / Locations
- Evangelische Kliniken Essen MitteRecruiting
- Charité University Hospital BerlinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
No Intervention
No Intervention
Experimental
Control Group 1
Control Group 2
Control Group 3
Intervention Group
Historic control group from both study sites: patients who took part in the FRAILTY study at Charité University hospital Berlin, as well as patients who were treated for OC at Evangelische Kliniken Essen Mitte during the same time period. Retrospective analysis looking at some of the main outcome variables will be conducted.
Prospective control group: patients who undergo treatment for OC at both sites. Main outcomes are determined while under standard hospital care before start of the change management and implementation of the new intervention.
Control group for health economical analysis to determine the cost-effectiveness of the new intervention.
Intervention Group undergoing the new multi-modal perioperative care pathway, including the implementation of ERAS pathway, in combination with a tri-modal prehabilitation program following a comprehensive frailty assessment.