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

Ann-Kristine Weber Giger; Helena Møgelbjerg Ditzel; Trine Lembrecht Jørgensen; Henrik Jørn Ditzel; Afsaneh Mohammadnejad; Marianne Ewertz; Per Pfeiffer; Cecilia Margareta Lund; Jesper Ryg

doi:10.1016/j.jgo.2021.07.005

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

J Geriatr Oncol. 2022 Jan;13(1):116-123. doi: 10.1016/j.jgo.2021.07.005. Epub 2021 Aug 4.

Authors

Ann-Kristine Weber Giger¹, Helena Møgelbjerg Ditzel², Trine Lembrecht Jørgensen², Henrik Jørn Ditzel², Afsaneh Mohammadnejad³, Marianne Ewertz⁴, Per Pfeiffer², Cecilia Margareta Lund⁵, Jesper Ryg⁶

Affiliations

¹ Department of Geriatric Medicine, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark. Electronic address: Ann-Kristine.Weber.Giger@rsyd.dk.
² Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Oncology, Odense University Hospital, Denmark.
³ Department of Public Health, University of Southern Denmark, Denmark.
⁴ Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark.
⁵ Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Medicine, Copenhagen University Hospital, Herlev and Gentofte, Denmark; CopenAge, Copenhagen Center for Clinical Age research, University of Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
⁶ Department of Geriatric Medicine, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark.

PMID: 34362713
DOI: 10.1016/j.jgo.2021.07.005

Abstract

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.

Keywords: Comprehensive geriatric assessment; Frailty; Geriatric 8; Geriatric oncology; Older adults.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Early Detection of Cancer
Geriatric Assessment / methods
Humans
Neoplasms* / diagnosis
Neoplasms* / drug therapy
Prognosis
Quality of Life*
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT04686851