GERiatric Screening in the treatment of elderly patients with Ovarian Carcinoma (GERSOC): study protocol for a pragmatic, cluster randomised controlled trial

Neeltje J van Soolingen*, Carolina H Smorenburg, Marije E Hamaker, Wim G Groen, Valesca P Retèl, Christianne A R Lok, Lonneke V van de Poll-Franse, Johannes W Trum

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)
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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.

Original languageEnglish
Pages (from-to)214
JournalTrials
Volume21
Issue number1
DOIs
Publication statusPublished - 22 Feb 2020
Externally publishedYes

Bibliographical note

Funding:
This trial is funded by a grant in the ‘Health Care Efficiency Research’
programme from The Netherlands Organisation for Health Research and
Development (ZonMw), project number 843004102. The funding body had
no role in the design of the study and will not be involved in data
collection, analysis and interpretation.

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