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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05256576

Studienbeginn:
Juli 2020

Letztes Update:
16.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Ovarian Neoplasms, Fallopian Tube Neoplasms, Frailty

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
Kliniken Essen-Mitte

Studienlocations
(2 von 2)

Evangelische Kliniken Essen Mitte
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Stephanie Schneider, MD
Phone: +4915165111716
E-Mail: st.schneider@kem-med.com» Ansprechpartner anzeigen

Charité University Hospital Berlin
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Melisa Gülhan Inci, MD, MSc
Phone: +4930450664346
E-Mail: guelhan.inci@charite.de

Marlene M Lee, MSc
Phone: +4930450664036
E-Mail: marlene.lee@charite.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Severe postoperative complications Clavien Dindo Classification III-V (Time Frame - up until postoperative day 60):
CDC III-V

Secondary outcome:

1. Postoperative complications Clavien Dindo Classification I-II (Time Frame - up until postoperative day 60):
CDC I-II

2. Postoperative morbidity (Time Frame - post-operative day 30, 60, 90)

3. Length of hospital stay (Time Frame - up until postoperative day 90)

4. Re-hospitalisation-rate (Time Frame - up until postoperative day 90)

5. Hospital staff compliance (Time Frame - up until postoperative day 60):
Compliance to ERAS-items will be monitored and entered into the EIAS database for ERAS-compliance monitoring

6. Fried Frailty assessment modified by Inci (Time Frame - 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.

7. Postoperative mortality (Time Frame - up until postoperative day 90)

8. EORTC QLQ-C30 questionnaire (Time Frame - up until postoperative day 60)

9. EQ-5D-3L questionnaire (Time Frame - up until postoperative day 60)

10. EORTC QLQ-OV 28 questionnaire (Time Frame - up until postoperative day 60)

11. Questionnaire regarding outpatient health care expenses of patients (Time Frame - up until postoperative day 60)

Studien-Arme

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.

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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