Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT)

Aug 7, 2021Journal of geriatric oncology

How well cancer screening and health assessments predict outcomes in older cancer patients: A clinical trial plan

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Abstract

The study aims to enroll 134 patients in the palliative group and 188 in the curative group to evaluate the effects of comprehensive geriatric assessment on older patients with cancer.

Comprehensive geriatric assessment (CGA) is being tested as an additional intervention alongside standard cancer treatment.
Patients aged 70 and older with solid tumors and frailty, as identified by the Geriatric 8 (G8) tool, are eligible for the trial.
Primary endpoints include physical decline measured by the 30-second Chair-Stand-Test at three months for the palliative group and unplanned hospital admissions at six months for the curative group.
Outcomes will also assess quality of life, treatment toxicity and adherence, polypharmacy issues, potential drug interactions, and survival.
The study includes an ongoing recruitment process which began in November 2020, with 37 and 29 patients enrolled by April 15, 2021.

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INTRODUCTION: Comprehensive geriatric assessment (CGA) has been shown to reduce frailty in older patients in general. In older patients with cancer, frailty affects quality of life (QoL), physical function, and survival. However, few studies have examined the effect of CGA as an additional intervention to antineoplastic treatment. This protocol presents a randomized controlled trial, which aims to evaluate the effects of CGA-based interventions in older patients with cancer and Geriatric 8 (G8) identified frailty.

MATERIALS AND METHODS: This randomized controlled trial will include patients, age 70+ years, with solid malignancies and G8 frailty (G8 ≤ 14). Patients will be separated into two groups, with different primary endpoints, depending on palliative or curative antineoplastic treatment initiation, and subsequently randomized 1:1 to either CGA with corresponding interventions or standard of care, along with standardized antineoplastic treatment. A geriatrician led CGA with corresponding interventions and clinical follow-up will be conducted within one month of antineoplastic treatment initiation. The interdisciplinary CGA will cover multiple geriatric domains and employ a standard set of validated assessment tools. Primary endpoints will be physical decline measured with the 30-s Chair-Stand-Test at three months (palliative setting) and unplanned hospital admissions at six months (curative setting). Additional outcomes include QoL, treatment toxicity and adherence, occurrence of polypharmacy, potential drug interactions, potential inappropriate medications, and survival. The primary outcomes will be analyzed using a mixed model regression analysis (30-s chair stand test) and linear regression models (unplanned hospitalizations), with an intention to treat approach. Power calculations reveal the need to enroll 134 (palliative) and 188 (curative) patients.

DISCUSSION: The present study will examine whether CGA, as an additional intervention to antineoplastic treatment, can improve endpoints valued by older patients with cancer. Inclusion began November 2020 and is ongoing, with 37 and 29 patients recruited April 15th, 2021. Registration:NCT04686851.

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Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT)

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