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Clinical trial
The KORE-INNOVATION trial, a prospective controlled multi-site clinical study to implement and assess the effects of an innovative peri-operative care pathway for patients with ovarian cancer: rationale, methods and trial design
  1. Melisa Guelhan Inci1,
  2. Jalid Sehouli1,
  3. Eva Schnura2,
  4. Marlene Lee1,
  5. Stephanie Roll3,
  6. Thomas Reinhold3,
  7. Julia Klews4,
  8. Lutz Kaufner5,
  9. Phil Niggemann5,
  10. Harald Groeben6,
  11. Julia Toelkes6,
  12. Anett Reisshauer7,
  13. Max Liebl7,
  14. Enrico Daehnert4,
  15. Manuela Zimmermann4,8,
  16. Barbora Knappe-Drzikova9,
  17. Susanne Rolker10,
  18. Björn Nunier11,
  19. Engi Algharably12,
  20. Adak Pirmorady Sehouli13,
  21. Lena Zwantleitner14,
  22. Andrea Krull15,
  23. Florian Heitz2,
  24. Beyhan Ataseven2,16,
  25. Radoslav Chekerov1,
  26. Philipp Harter2 and
  27. Stephanie Schneider2
  1. 1Department of Gynecology with Center for Oncological Surgery, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité Comprehensive Cancer Center, Berlin, Germany
  2. 2Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH Klinik fur Gynakologie & Gynakologische Onkologie, Essen, Germany
  3. 3Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité Comprehensive Cancer Center, Berlin, Germany
  4. 4Business Division – Nursing Science, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
  5. 5Department of Anesthesiology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
  6. 6Department of Anaesthesia, Critical Care Medicine and Pain Therapy, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany
  7. 7Department of Physical Medicine, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
  8. 8Akkon University of Humanities, Berlin, Germany
  9. 9Nutrition and Diabetes advisor (DDG) and Dietitian for parental nutrition therapy (VDD), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
  10. 10Nutrition and Diabetes advisor (DDG) and Dietitian for parental nutrition therapy (VDD), Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany
  11. 11Department of Ergo-, Logo-, and Physiotherapy, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany
  12. 12Institute for Clinical Pharmacology and Toxicology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
  13. 13Department of Psychosomatic Medicine and Psychotherapy, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité Comprehensive Cancer Center, Berlin, Germany
  14. 14Fachbereich Versorgungsmanagement, Techniker Krankenkasse, Hamburg, Germany
  15. 15Eierstockkrebs Schwerpunkt, Verein Gynäkologische Krebserkrankungen Deutschland e.V, Neumünster, Germany
  16. 16Academic Department of Gynecology, Gynecologic Oncology and Obstetrics, Bielefeld University, Medical School and University Medical Center East Westphalia-Lippe, Klinikum Lippe, Detmold, Germany
  1. Correspondence to Dr Melisa Guelhan Inci, 1Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Gynecology with Center for Oncological Surgery, Charité Comprehensive Cancer Center, Augustenburger Platz 1, 13353 Berlin, Germany, Berlin 13353, Germany; guelhan.inci{at}charite.de

Abstract

Background Advanced ovarian cancer is managed by extensive surgery, which could be associated with high morbidity. A personalized pre-habilitation strategy combined with an ‘enhanced recovery after surgery’ (ERAS) pathway may decrease post-operative morbidity.

Primary Objective To analyze the effects of a combined multi-modal pre-habilitation and ERAS strategy on severe post-operative morbidity for patients with ovarian cancer (primary diagnosis or first recurrence) undergoing cytoreductive surgery.

Study Hypothesis A personalized multi-modal pre-habilitation algorithm entailing a physical fitness intervention, nutritional and psycho-oncological support, completed by an ERAS pathway, reduces post-operative morbidity.

Trial Design This is a prospective, controlled, non-randomized, open, interventional two-center clinical study. Endpoints will be compared with a three-fold control: (a) historic control group (data from institutional ovarian cancer databases); (b) prospective control group (assessed before implementing the intervention); and (c) matched health insurance controls.

Inclusion Criteria Patients with ovarian, fallopian, or primary peritoneal cancer undergoing primary surgical treatment (primary ovarian cancer or first recurrence) can be included. The intervention group receives an additional multi-level study treatment: (1) standardized frailty assessment followed by (2) a personalized tri-modal pre-habilitation program and (3) peri-operative care according to an ERAS pathway.

Exclusion Criteria Inoperable disease or neoadjuvant chemotherapy, simultaneous diagnosis of simultaneous primary tumors, in case of interference with the overall prognosis (except for breast cancer); dementia or other conditions that impair compliance or prognosis.

Primary Endpoint Reduction of severe post-operative complications (according to Clavien– Dindo Classification (CDC) III–V) within 30 days after surgery.

Sample Size Intervention group (n=414, of which approximately 20% insure with the participating health insurance); historic control group (n=198); prospective control group (n=50), health insurance controls (for those intervention patients who are members of the participating health insurance).

Estimated Dates for Completing Accrual and Presenting Results The intervention phase started in December 2021 and will continue until June 2023. As of March 2023, 280 patients have been enrolled in the intervention group. The expected completion of the entire study is September 2024.

Trial Registration NCT05256576.

  • Gynecologic Surgical Procedures
  • Ovarian Cancer

http://dx.doi.org/10.1136/ijgc-2023-004531

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    Footnotes

    • Contributors MGI, JS, SS, PH: Conceptualization, methodology, acquisition, project administration, writing—original draft preparation, writing—editing, funding. ES, ML, SR, TR, ED, MZ, LZ, AK: Conceptualization, methodology, validation, acquisition, project administration. JK, LK, PN, HG, JT, AR, ML, BK-D, SR, BN, EA, APS, FH, BA, RC: Acquisition, formal analysis, investigation—review. All authors have read and agreed to the published version of the manuscript. MGI accepts full responsibility for the finished work and the conduct of the study, had access to the data, and controlled the decision to publish.

    • Funding This study is funded by the German “Innovationsfonds des Gemeinsamen Bundesausschuss” (01NVF18021), which is a non-profit fund tasked with promoting healthcare research projects to further develop the quality of care in Germany’s statutory health insurance system. The results will be discussed between healthcare professionals, the insurance companies, and the government to translate this concept into the clinical routine.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; internally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.