Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05256576 |
| Other study ID # |
01NVF18021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Charite University, Berlin, Germany |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
