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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT05256576

Collaborator

Kliniken Essen-Mitte (Other)

414

Enrollment

Locations

Arms

Anticipated Duration (Months)

207

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovary Cancer Fallopian Tube Cancer Peritoneum Cancer Frailty	Other: Implementation of an innovative multi-modal peri-operative care pathway	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

414 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

multi-center, controlled, open-ended intervention studymulti-center, controlled, open-ended intervention study

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group 1 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.
No Intervention: Control Group 2 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.
No Intervention: Control Group 3 Control group for health economical analysis to determine the cost-effectiveness of the new intervention.
Experimental: Intervention Group 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.	Other: Implementation 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.

Outcome Measures

Primary Outcome Measures

Severe postoperative complications Clavien Dindo Classification III-V [up until postoperative day 60]
CDC III-V

Secondary Outcome Measures

Postoperative complications Clavien Dindo Classification I-II [up until postoperative day 60]
CDC I-II
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 mortality [up until postoperative day 90]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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