Clinical trial NCT05256576: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovary Cancer
Fallopian Tube Cancer
Peritoneum Cancer
Frailty
Keywords: Perioperative care
Prehabilitation
Enhanced Recovery after Surgery
Patient Empowerment
Postoperative Complications
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Kliniken Essen-Mitte
First posted: 2022-02-25
Enrollment: 465
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: multi-center, controlled, open-ended intervention study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Severe postoperative complications Clavien Dindo Classification III-V
timeFrame: up until postoperative day 60
Secondary outcomes:
measure: Postoperative complications Clavien Dindo Classification I-II
timeFrame: up until postoperative day 60
measure: Postoperative morbidity
timeFrame: post-operative day 30, 60, 90
measure: Length of hospital stay
timeFrame: up until postoperative day 90
measure: Re-hospitalisation-rate
timeFrame: up until postoperative day 90
measure: Hospital staff compliance
timeFrame: up until postoperative day 60
measure: Fried Frailty assessment modified by Inci
timeFrame: 3 weeks pre operation up until 30 days post operation
measure: Postoperative mortality
timeFrame: up until postoperative day 90
measure: EORTC QLQ-C30 questionnaire
timeFrame: up until postoperative day 60
measure: EQ-5D-3L questionnaire
timeFrame: up until postoperative day 60
measure: EORTC QLQ-OV 28 questionnaire
timeFrame: up until postoperative day 60
measure: Questionnaire regarding outpatient health care expenses of patients
timeFrame: up until postoperative day 60
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Evangelische Kliniken Essen Mitte
state: Nordrhein Westfalen
city: Berlin
country: Germany
facility: Charité University Hospital Berlin
Study officials:
References: