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. 2020 Feb 22;21(1):214.
doi: 10.1186/s13063-020-4157-y.

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  1 , Carolina H Smorenburg  2 , Marije E Hamaker  3 , Wim G Groen  4 , Valesca P Retèl  4   5 , Christianne A R Lok  6 , Lonneke V van de Poll-Franse  4   7   8 , Johannes W Trum  6
Affiliations

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 et al. Trials. .

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.

Keywords: Cluster randomisation; Cost-effectiveness; Elderly; Frailty; Geriatric screening; Health-related quality of life; Ovarian cancer; Treatment completion.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design of the GERSOC-trial
Fig. 2
Fig. 2
Schematic outline of study procedures in the GERSOC-trial
Fig. 3
Fig. 3
SPIRIT figure: overview of enrolment, interventions and assessments in the GERSOC-trial
See this image and copyright information in PMC

References

    1. Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, et al. Global Cancer Observatory: Cancer Today. Lyon: International Agency for Research on Cancer; 2018.
    1. The Netherlands Cancer Registry (NCR), IKNL. 2019. https://iknl.nl/nkr-cijfers. Accessed 31 Jan 2020.
    1. Schuurman MS, Kruitwagen RFPM, Portielje JEA, Roes EM, Lemmens VEPP, van der Aa MA. Treatment and outcome of elderly patients with advanced stage ovarian cancer: A nationwide analysis. Gynecol Oncol. 2018;149(2):270–274. doi: 10.1016/j.ygyno.2018.02.017. - DOI - PubMed
    1. Guideline Commission Gynaecologic Oncology (CRGO). Dutch Guideline Epithelial Ovarian Carcinoma, version 2.2. 2018. https://www.oncoline.nl/ovariumcarcinoom. Accessed 31 Jan 2020.
    1. Wright AA, Bohlke K, Armstrong DK, Bookman MA, Cliby WA, Coleman RL, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2016;34(28):3460–3473. doi: 10.1200/JCO.2016.68.6907. - DOI - PMC - PubMed

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