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© The Author(s). 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

Approximately 40% of the newly diagnosed patients with advanced ovarian cancer are aged 70 years or older. Standard treatment for advanced disease consists of cytoreductive surgery and combination chemotherapy. In older patients, standard treatment is often withheld or prematurely stopped due to suspected frailty. It remains challenging to distinguish fit elderly patients who can endure standard therapy from frail patients who may benefit from an adapted treatment strategy. As a comprehensive geriatric assessment (CGA) can contribute to the identification of frail patients and improve tailored therapy in this population, screening tests were developed to select those who may benefit from a CGA. However, the use of these geriatric screening tests has rarely been compared with usual clinical care. The GERSOC-trial will evaluate whether geriatric screening in elderly patients with advanced-stage ovarian cancer improves treatment completion and quality of life.

Methods

This pragmatic, cluster randomised controlled trial will be conducted at a minimum of 20 hospitals in the Netherlands. Hospitals are randomly assigned to geriatric screening care (in which a geriatric screening comprised of the G8 questionnaire and the Timed Up and Go test is performed), or care as usual (in which current usual care is continued). A total of 320 patients aged ≥ 70 years with primary, advanced-stage ovarian carcinoma will be included. Patients considered fit on geriatric screening will receive standard treatment; patients who are considered unfit will be referred to a geriatrician for analysis and treatment advice. The primary outcome is the percentage difference in completed standard and adapted therapies between the two study arms. Secondary outcomes include quality of life, cost-effectiveness and survival.

Discussion

This trial aims to gather evidence for the use of geriatric screening in treatment decision-making in elderly patients with advanced ovarian cancer. If proven feasible, beneficial and cost-effective, geriatric screening may be implemented in routine clinical practice.

Trial registration

Netherlands Trial Registry, ID: NL6745. Registered on 2 August 2017.

Details

Title
GERiatric Screening in the treatment of elderly patients with Ovarian Carcinoma (GERSOC): study protocol for a pragmatic, cluster randomised controlled trial
Author
van Soolingen, Neeltje J. 1   VIAFID ORCID Logo  ; Smorenburg, Carolina H. 2 ; Hamaker, Marije E. 3 ; Groen, Wim G. 4 ; Retèl, Valesca P. 5 ; Lok, Christianne A. R. 1 ; van de Poll-Franse, Lonneke V. 6 ; Trum, Johannes W. 1 

 The Netherlands Cancer Institute, Department of Gynaecologic Oncology, Centre for Gynaecologic Oncology Amsterdam, Amsterdam, The Netherlands (GRID:grid.430814.a) 
 The Netherlands Cancer Institute, Department of Medical Oncology, Amsterdam, The Netherlands (GRID:grid.430814.a) 
 Department of Geriatric Medicine, Diakonessenhuis Utrecht, Utrecht, The Netherlands (GRID:grid.430814.a) 
 The Netherlands Cancer Institute, Division of Psychosocial Research and Epidemiology, Amsterdam, The Netherlands (GRID:grid.430814.a) 
 The Netherlands Cancer Institute, Division of Psychosocial Research and Epidemiology, Amsterdam, The Netherlands (GRID:grid.430814.a); University of Twente, Department of Health Technology and Services Research (HTSR), Enschede, The Netherlands (GRID:grid.6214.1) (ISNI:0000 0004 0399 8953) 
 The Netherlands Cancer Institute, Division of Psychosocial Research and Epidemiology, Amsterdam, The Netherlands (GRID:grid.430814.a); Tilburg University, CoRPS – Center of Research on Psychology in Somatic diseases, Department of Medical and Clinical Psychology, Tilburg, The Netherlands (GRID:grid.12295.3d) (ISNI:0000 0001 0943 3265); The Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands (GRID:grid.470266.1) (ISNI:0000 0004 0501 9982) 
Pages
214
Publication year
2020
Publication date
Dec 2020
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2730331817
Copyright
© The Author(s). 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.