Fallopian Tube Cancer, Frailty, Ovary Cancer, Peritoneum Cancer
Conditions
Keywords
Perioperative care, Prehabilitation, Enhanced Recovery after Surgery, Patient Empowerment, Postoperative Complications
Brief summary
KORE-INNOVATION is a multi-center clinical study aiming to implement and analyze an innovative care pathway to reduce perioperative complications for patients undergoing surgical treatment for ovarian cancer. This is achieved by a structured, multidisciplinary implementation of the ERAS pathway, as well as introducing a tri-modal prehabilitation program, following a comprehensive frailty-assessment. The patient-individualized prehabilitation program consists of a structured plan to improve physical fitness, nutritional status, as well as patient empowerment. The aim of the study is to reduce perioperative morbidity and mortality, as well as improvement in quality of life.
Detailed description
The treatment of patients with ovarian, fallopian tube or peritoneal cancer (OC) usually consists of a primary operation, followed by platinum-based chemotherapy and targeted maintenance therapy. According to various studies, complete macroscopic resection is considered the most important predictive factor for overall survival. Due to a lack of early detection, the majority of OC-cases are diagnosed at an advanced tumor stage. Therefore, the surgical treatment is often characterized by multi-visceral resections, in order to achieve complete macroscopic resection of the tumor mass. The rate of serious postoperative complications after debulking surgery (CDC III°-V° (Clavien-Dindo-Classification)) is about 29%. These complications are often associated with longer hospital stays and a delay in the start of the consecutive treatment, which is crucial for the overall prognosis and quality of life of OC-patients. This study aims to implement and analyze the effect of an innovative multimodal care pathway to reduce the rate of serious complications 30 and 60 days postoperatively in patients with a primary diagnosis of OC or first platinum-sensitive recurrence of an OC, compared to patients undergoing routine treatment. The new care pathway consists of two main components: firstly, a frailty-adapted, individualized tri-modal prehabilitation program, consisting of a respective physical fitness module, an individualized nutrition plan, as well as patient empowerment. The empowerment module aims to educate patients to make informed decisions and take an active role in the recovery process, as well as build psychological resilience and activate psychosocial resources through individual and group-coaching sessions. Secondly this is combined with the implementation of the established perioperative ERAS (Enhanced Recovery after Surgery)-concept, in order to provide optimized care to patients with OC, as well as reduce the length of hospital stay and reduce health-care costs. This study is a prospective, multicenter, controlled interventional study consisting of three phases. 1. Baseline phase, including the analysis of a prospective control group by monitoring perioperative patient care under standard care conditions. 2. Change management, which entails the preparation of the intervention phase. This consists of the integration of the new treatment procedures (prehabilitation and ERAS-pathway) into regular care. The establishment of interdisciplinary and inter-professional care teams, as well as the implementation of a training program are additional key factors. 3. Intervention phase, which entails the treatment of patients according to the new care pathway and the analysis of its effects in a prospective intervention group. The KORE-INNOVATION project funded by the government and has been in the preparatory phase since July 2020.The baseline phase was conducted from April 2021 until October 2021. Change management took place from July 2021 until November 2021. The intervention phase started in December 2021 and will be going forward until June 2023. To the best of our knowledge, this is the first attempt to implement a multimodal care pathway introducing an individualized frailty adapted, tri-modal prehabilitation program in combination with the ERAS-pathway to reduce postoperative morbidity and mortality, length of hospital stay, and health-care costs in patients with OC.
Interventions
OTHERImplementation of an innovative multi-modal peri-operative care pathway
The innovative multi-modal care pathway includes the implementation of the ERAS pathway, as well as the introduction of a patient-specific tri-modal prehabilitation program. This consists of a physical fitness, nutrition, and patient empowerment intervention.
Sponsors
Kliniken Essen-Mitte
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
multi-center, controlled, open-ended intervention study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe postoperative complications Clavien Dindo Classification III-V | up until postoperative day 60 | CDC III-V |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity | post-operative day 30, 60, 90 | — |
| Length of hospital stay | up until postoperative day 90 | — |
| Re-hospitalisation-rate | up until postoperative day 90 | — |
| Hospital staff compliance | up until postoperative day 60 | Compliance to ERAS-items will be monitored and entered into the EIAS database for ERAS-compliance monitoring |
| Fried Frailty assessment modified by Inci | 3 weeks pre operation up until 30 days post operation | A comprehensive geriatric asessment according to Fried's frailty assessment will be conducted. This includes the following tests: timed up and go test, and grip strength test. Questions included in the assessment are: weight loss \>5kg in the past year, occurence of fatigue in the past week, activity level. Patients are then grouped into three categories: non-frail, pre-frail, and frail. |
| Postoperative complications Clavien Dindo Classification I-II | up until postoperative day 60 | CDC I-II |
| EORTC QLQ-C30 questionnaire | up until postoperative day 60 | — |
| EQ-5D-3L questionnaire | up until postoperative day 60 | — |
| EORTC QLQ-OV 28 questionnaire | up until postoperative day 60 | — |
| Questionnaire regarding outpatient health care expenses of patients | up until postoperative day 60 | — |
| Postoperative mortality | up until postoperative day 90 | — |
Countries
Germany
Outcome results
None listed