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).

癌症会影响不同程度虚弱的老年人，但癌症治疗是从主要涉及年轻和强壮受试者的临床试验中推断出来的。最近的老年肿瘤学随机对照试验 (RCT) 报告称，导致衰弱指导干预的老年学评估可降低治疗相关的毒性，同时维持生存和改善生活质量 (QoL)。然而，这些积极的结果并没有在文献中得到一致的报道。我们假设在这些研究中低估了老年干预的影响，因为这些研究纳入了接受姑息性化疗的受试者，这些受试者中剂量减少是常见的。将支持性护理与当前的老年肿瘤学模型相结合可能会改善接受治疗的老年人的生活质量。然而，

老年人肿瘤支持诊所 (GOSPEL) 研究是一项单中心、开放标签、分析员设盲的随机对照试验，旨在评估综合老年和支持性护理对接受治愈性治疗的老年癌症患者生活质量的影响。将招募 65 岁以上、Geriatric-8 评分≤14 且计划进行高剂量放疗和/或治愈性化疗的老年人。主要 QoL 结果是在 12 周时使用欧洲癌症研究和治疗组织 (EORTC) QLQ-ELD14 活动量表测量的。次要结果包括总生存期和无病生存期、治疗相关不良事件和住院率。我们根据 EORTC QLQ-ELD14 的最小临床重要差异对这项研究进行了预先验证，以招募 200 名受试者，以达到 80% 的统计功效 (alpha 0.05)，假设 25% 的损耗。将使用意向治疗分析结果。

干预包括针对未满足需求的多学科团队进行的多领域综合老年病学和支持性护理评估。这些包括功能衰退、跌倒、大小便失禁、认知障碍、多种疾病、多重用药和症状缓解，以及社会和心理-精神问题。标准护理需要常规肿瘤学管理，并根据主要肿瘤学家的判断转诊至老年病学。自 2020 年 8 月以来一直在进行招募。GOSPEL 研究的结果将增加人们对综合老年和支持性护理计划对接受治愈性治疗的癌症老年人的影响的理解。

试验注册：本研究已在 ClinicalTrials.gov (ID NCT04513977) 下注册。