Effectiveness of comprehensive geriatric assessment with extensive patient coaching for improving quality of life in older patients with solid tumours receiving systemic therapy (G-oncoCOACH): a multicentre randomised controlled trial

BACKGROUND: Comprehensive geriatric assessment (CGA) has demonstrated numerous benefits in older patients with cancer, and is internationally recommended, but more data are needed on its impact on quality of life (QoL). The aim of the G-oncoCOACH study is to evaluate the effectiveness of CGA on QoL in older patients with solid tumours receiving systemic therapy by integrating a geriatric team for implementing geriatric assessment (GA)-based recommendations and offering extensive patient coaching compared with standard of care in oncology. METHODS: The G-oncoCOACH study was a multicentre randomised controlled trial conducted in two academic hospitals in Belgium. Patients aged 70 years or older with solid tumours initiating systemic therapy with curative or non-curative intent, and physician-estimated life expectancy of at least 6 months, were randomly assigned (1:1) to either the control group (standard oncology care; receiving GA-based recommendations implemented by the oncology team) or the intervention group (receiving GA-based recommendations implemented by a geriatric team and intensive patient coaching). There was no masking of participants, physicians, or study personnel. The primary outcome was change in global health status (GHS) from baseline to 6 months, measured using the EORTC QLQ-C30 questionnaire (ie, QoL GHS). Linear mixed models were used for data analysis. Exploratory analyses evaluated predictors for change in QoL GHS. The trial is registered with ClinicalTrials.gov (NCT04069962), and is completed. FINDINGS: Between Oct 30, 2019, and Aug 5, 2021, 217 participants were enrolled and randomly assigned, of whom 212 had QoL GHS available at baseline (107 in the control group, 105 in the intervention group). Among these 212 participants, the mean age was 76·7 years; 111 (52%) were female and 101 (48%) male. The three most common tumour types were lung cancer (41 [19%]), colorectal cancer (31 [15%]), and breast cancer (22 [10%]). The mean difference in QoL GHS score between the intervention group and the control group at 6 months was 10·9 points (95% CI 3·7-18·0; p=0·0030) in favour of the intervention group, and confirmed by a sensitivity analysis. Adherence to GA-based recommendations was higher in the intervention group (71 [65%] of 110 recommendations implemented) than the control group (67 [45%] of 148 recommendations implemented). Exploratory analyses revealed significant predictors for change in QoL GHS, such as low baseline QoL GHS and high comorbidity. INTERPRETATION: The G-oncoCOACH study shows that CGA with the integration of a geriatric team for implementing GA-based recommendations and offering extensive patient coaching improves QoL GHS in older patients with cancer compared with standard of care in oncology. FUNDING: Stand Up to Cancer (Kom op tegen Kanker).