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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Ovarian Cancer | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2020

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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.
Appendix
Available only for authorised users
Literature
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. https://​gco.​iarc.​fr/​today. Accessed 31 Jan 2020.
2.
3.
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):270–4.CrossRef
4.
5.
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):3460–73.CrossRef
6.
Wildiers H, Mauer M, Pallis A, Hurria A, Mohile SG, Luciani A, et al. End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer--Alliance for Clinical Trials in Oncology--International Society Of Geriatric Oncology position article. J Clin Oncol. 2013;31(29):3711–8.CrossRef
7.
Fourcadier E, Trétarre B, Gras-Aygon C, Ecarnot F, Daurès JP, Bessaoud F. Under-treatment of elderly patients with ovarian cancer: a population based study. BMC Cancer. 2015;15:937.CrossRef
8.
Fairfield KM, Murray K, Lucas FL, Wierman HR, Earle CC, Trimble EL, et al. Completion of adjuvant chemotherapy and use of health services for older women with epithelial ovarian cancer. J Clin Oncol. 2011;29(29):3921–6.CrossRef
9.
Maas HAAM, Kruitwagen RFPM, Lemmens VEPP, Goey SH, Janssen-Heijnen ML. The influence of age and co-morbidity on treatment and prognosis of ovarian cancer: a population-based study. Gynecol Oncol. 2005;97(1):104–9.CrossRef
10.
Sabatier R, Calderon B Jr, Lambaudie E, Chereau E, Provansal M, Cappiello MA, et al. Prognostic factors for ovarian epithelial cancer in the elderly: a case-control study. Int J Gynecol Cancer. 2015;25(5):815–22.CrossRef
11.
van Walree IC, van Soolingen NJ, Hamaker ME, Smorenburg CH, Louwers JA, van Huis-Tanja LH. Treatment decision-making in elderly women with ovarian cancer: an age-based comparison. Int J Gynecol Cancer. 2019;29(1):158–65.CrossRef
12.
Tan HJ, Saliba D, Kwan L, Moore AA, Litwin MS. Burden of geriatric events among older adults undergoing major cancer surgery. J Clin Oncol. 2016;34(11):1231–8.CrossRef
13.
Moore KN, Reid MS, Fong DN, Myers TKN, Landrum LM, Moxley KM, et al. Ovarian cancer in the octogenarian: does the paradigm of aggressive cytoreductive surgery and chemotherapy still apply? Gynecol Oncol. 2008;110(2):133–9.CrossRef
14.
Fotopoulou C, Savvatis K, Steinhagen-Thiessen E, Bahra M, Lichtenegger W, Sehouli J. Primary radical surgery in elderly patients with epithelial ovarian cancer: analysis of surgical outcome and long-term survival. Int J Gynecol Cancer. 2010;20(1):34–40.CrossRef
15.
16.
Clegg A, Young J, Iliffe S, Olde Rikkert M, Rockwood K. Frailty in elderly people. Lancet. 2013;381(9868):752–62.CrossRef
17.
Wildiers H, Heeren P, Puts M, Topinkova E, Janssen-Heijnen ML, Extermann M, et al. International Society of Geriatric Oncology consensus on geriatric assessment in older patients with cancer. J Clin Oncol. 2014;32(24):2595–603.CrossRef
18.
Decoster L, Van Puyvelde K, Mohile S, Wedding U, Basso U, Colloca G, et al. Screening tools for multidimensional health problems warranting a geriatric assessment in older cancer patients: an update on SIOG recommendations. Ann Oncol. 2015;26(2):288–300.CrossRef
19.
Bellera CA, Rainfray M, Mathoulin-Pélissier S, Mertens C, Delva F, Fonck M, et al. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012;23(8):2166–72.CrossRef
20.
Hamaker ME, Jonker JM, de Rooij SE, Vos AG, Smorenburg CH, van Munster BC. Frailty screening methods for predicting outcome of a comprehensive geriatric assessment in elderly patients with cancer: a systematic review. Lancet Oncol. 2012;13(10):e437–e44.CrossRef
21.
Podsiadlo D, Richardson S. The timed "up & go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142–8.CrossRef
22.
Verweij NM, Schiphorst AH, Pronk A, van den Bos F, Hamaker ME. Physical performance measures for predicting outcome in cancer patients: a systematic review. Acta Oncol. 2016;55(12):1386–91.CrossRef
23.
24.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.CrossRef
25.
Greimel E, Bottomley A, Cull A, Waldenstrom AC, Arraras J, Chauvenet L, et al. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. Eur J Cancer. 2003;39(10):1402–8.CrossRef
26.
Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35(11):1095–108.CrossRef
27.
Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. Handleiding iMTA Medical Consumption Questionnaire (iMCQ). Rotterdam: institute for Medical Technology Assessment, Erasmus Universiteit Rotterdam; 2013.
28.
Campbell MK, Elbourne DR, Altman DG, CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328(7441):702–8.CrossRef
29.
Austin PC. A tutorial on multilevel survival analysis: Methods, models and applications. Int Stat Rev. 2017;85(2):185–203.CrossRef
30.
Hox JJ. Multilevel analysis: Techniques and applications. 2nd ed. New York: Routledge; 2010.CrossRef
31.
Twisk JWR. Applied multilevel analysis. A practical guide. 1th ed. Cambridge: Cambridge University Press; 2006.CrossRef
32.
Twisk JWR. Applied longitudinal data analysis for epidemiology. A Practical Guide. 1th ed. Cambridge: Cambridge University Press; 2003.
33.
Cocks K, King MT, Velikova G, de Castro G Jr, Martyn St-James M, Fayers PM, et al. Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Eur J Cancer. 2012;48(11):1713–21.CrossRef
34.
Kanters TA, Bouwmans CAM, van der Linden N, Tan SS, Hakkaart-van Roijen L. Update of the Dutch manual for costing studies in health care. PLoS One. 2017;12(11):e0187477.CrossRef
35.
Briggs A, Sculpher M, Claxton K. Decision modelling for health economic evaluation. 1th ed. Oxford: Oxford University Press; 2006.
36.
37.
Mauskopf JA, Sullivan SD, Annemans L, Caro J, Mullins CD, Nuijten M, et al. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices--budget impact analysis. Value Health. 2007;10(5):336–47.CrossRef
38.
Metadata
Title
GERiatric Screening in the treatment of elderly patients with Ovarian Carcinoma (GERSOC): study protocol for a pragmatic, cluster randomised controlled trial
Authors
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
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4157-y

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