Protocol for a randomised controlled trial on impact of comprehensive geriatric and supportive assessment versus standard care in older adults with cancer undergoing curative treatment: The Geriatric Oncology SuPportive clinic for ELderly (GOSPEL) study

Abstract

Cancer affects older adults with varying levels of frailty, but cancer treatment is extrapolated from clinical trials involving predominantly young and robust subjects. Recent geriatric oncology randomised controlled trials (RCT) report that geriatric assessment leading to frailty-guided intervention reduces treatment-related toxicity whilst maintaining survival and improving quality of life (QoL). However, these positive results have not have been consistently reported in the literature. We postulate that the impact of geriatric interventions has been underestimated in these studies with the inclusion of subjects receiving palliative-intent chemotherapy in whom dose reduction is common. Integrating supportive care with current geriatric oncology models may improve the QoL of older adults undergoing treatment. However, no studies as yet have examined such integrated geriatric and supportive models of care. The Geriatric Oncology SuPportive clinic for Elderly (GOSPEL) study is a single-centre, open-label, analyst-blinded RCT evaluating the impact of comprehensive geriatric and supportive care on QoL of older adults with cancer undergoing curative treatment. Older adults aged above 65, with a Geriatric-8 score ≤ 14, with plans for high dose radiotherapy and/or curative chemotherapy will be recruited. The primary QoL outcome is measured using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-ELD14 mobility scale at 12 weeks. Secondary outcomes include overall and disease-free survival, treatment-related adverse events, and hospital admissions. We pre-powered this study to recruit 200 subjects based on the minimally clinically important difference for EORTC QLQ-ELD14 to achieve 80% statistical power (alpha 0.05), assuming 25% attrition. Outcomes will be analysed using intention-to-treat. Intervention consists of multi-domain comprehensive geriatric and supportive care assessments from a multidisciplinary team targeting unmet needs. These include functional decline, falls, incontinence, cognitive impairment, multi-morbidity, polypharmacy, and symptom relief, as well as social and psycho-spiritual concerns. Standard care entails routine oncological management with referral to geriatrics based on the discretion of the primary oncologist. Recruitment has been ongoing since August 2020. Results from the GOSPEL study will increase understanding of the impact of integrated geriatric and supportive care programs in older adults with cancer receiving curative treatment. Trial registration: This study is registered under ClinicalTrials.gov (ID NCT04513977).

Keywords: Chemotherapy; Comprehensive geriatric assessment; Curative-intent; Frailty; Geriatric oncology; Radiotherapy; Supportive care.