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; Valesca P Retèl; Christianne A R Lok; Lonneke V van de Poll-Franse; Johannes W Trum

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
, Carolina H Smorenburg
, Marije E Hamaker
, Valesca P Retèl
, Christianne A R Lok
, Lonneke V van de Poll-Franse
, Johannes W Trum

Division of Molecular Carcinogenesis, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Cancer Systems Biology Center (CSBC), The Netherlands Cancer Institute, Amsterdam, the Netherlands. The NKI Robotics and Screening Center (NRSC), The Netherlands Cancer Institute, Amsterdam, the Netherlands. [email protected].
Department of Medicine and Surgery - Geriatric Clinic Unit Department of Medicine Geriatric Rehabilitation, University Hospital of Parma, Italy.

Research output: Contribution to journal › Article › Academic › peer-review

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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 language	English
Pages (from-to)	214
Journal	Trials
Volume	21
Issue number	1
DOIs	https://doi.org/10.1186/s13063-020-4157-y
Publication status	Published - 22 Feb 2020

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Aged
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
Carcinoma, Ovarian Epithelial/therapy
Cost-Benefit Analysis
Cytoreduction Surgical Procedures
Female
Frail Elderly
Geriatric Assessment
Humans
Multicenter Studies as Topic
Netherlands
Nutritional Status
Ovarian Neoplasms/therapy
Pragmatic Clinical Trials as Topic
Quality of Life

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Cite this

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

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.",

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author = "\{van Soolingen\}, \{Neeltje J\} and Smorenburg, \{Carolina H\} and Hamaker, \{Marije E\} and Ret{\`e}l, \{Valesca P\} and Lok, \{Christianne A R\} and \{van de Poll-Franse\}, \{Lonneke V\} and Trum, \{Johannes W\}",

year = "2020",

month = feb,

day = "22",

doi = "10.1186/s13063-020-4157-y",

language = "English",

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pages = "214",

journal = "Trials",

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T1 - GERiatric Screening in the treatment of elderly patients with Ovarian Carcinoma (GERSOC)

T2 - study protocol for a pragmatic, cluster randomised controlled trial

AU - van Soolingen, Neeltje J

AU - Smorenburg, Carolina H

AU - Hamaker, Marije E

AU - Retèl, Valesca P

AU - Lok, Christianne A R

AU - van de Poll-Franse, Lonneke V

AU - Trum, Johannes W

PY - 2020/2/22

Y1 - 2020/2/22

N2 - 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.

AB - 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.

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KW - Cytoreduction Surgical Procedures

KW - Female

KW - Frail Elderly

KW - Geriatric Assessment

KW - Humans

KW - Multicenter Studies as Topic

KW - Netherlands

KW - Nutritional Status

KW - Ovarian Neoplasms/therapy

KW - Pragmatic Clinical Trials as Topic

KW - Quality of Life

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DO - 10.1186/s13063-020-4157-y

M3 - Article

SN - 1745-6215

VL - 21

SP - 214

JO - Trials

JF - Trials

IS - 1

ER -

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

Abstract

UN SDGs

Keywords

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