The Research Centre for Age-Related Functional Decline and Disease, Innlandet Hospital Trust, Box 68, 2312, Ottestad, Norway.
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Pb 1171 Blindern, Oslo, 0318, Norway.
BMC Med. 2024 Jun 10;22(1):232. doi: 10.1186/s12916-024-03446-4.
Geriatric assessment and management (GAM) improve outcomes in older patients with cancer treated with surgery or chemotherapy. It is unclear whether GAM may provide better function and quality of life (QoL), or be cost-effective, in a radiotherapy (RT) setting.
In this Norwegian cluster-randomised controlled pilot study, we assessed the impact of a GAM intervention involving specialist and primary health services. It was initiated in-hospital at the start of RT by assessing somatic and mental health, function, and social situation, followed by individually adapted management plans and systematic follow-up in the municipalities until 8 weeks after the end of RT, managed by municipal nurses as patients' care coordinators. Thirty-two municipal/city districts were 1:1 randomised to intervention or conventional care. Patients with cancer ≥ 65 years, referred for RT, were enrolled irrespective of cancer type, treatment intent, and frailty status, and followed the allocation of their residential district. The primary outcome was physical function measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30). Secondary outcomes were overall quality of life (QoL), physical performance, use and costs of health services. Analyses followed the intention-to-treat principle. Study registration at ClinicalTrials.gov ID NCT03881137.
We included 178 patients, 89 in each group with comparable age (mean 74.1), sex (female 38.2%), and Edmonton Frail Scale scores (mean 3.4 [scale 0-17], scores 0-3 [fit] in 57%). More intervention patients received curative RT (76.4 vs 61.8%), had higher irradiation doses (mean 54.1 vs 45.5 Gy), and longer lasting RT (mean 4.4 vs 3.6 weeks). The primary outcome was completed by 91% (intervention) vs 88% (control) of patients. No significant differences between groups on predefined outcomes were observed. GAM costs represented 3% of health service costs for the intervention group during the study period.
In this heterogeneous cohort of older patients receiving RT, the majority was fit. We found no impact of the intervention on patient-centred outcomes or the cost of health services. Targeting a more homogeneous group of only pre-frail and frail patients is strongly recommended in future studies needed to clarify the role and organisation of GAM in RT settings.
老年综合评估和管理（GAM）可改善接受手术或化疗治疗的老年癌症患者的预后。在放疗（RT）环境下，GAM 是否能提供更好的功能和生活质量（QoL），或者更具成本效益，目前尚不清楚。
在这项挪威的聚类随机对照试验中，我们评估了涉及专科和初级卫生服务的 GAM 干预的影响。它是在 RT 开始时在医院内启动的，通过评估躯体和心理健康、功能和社会状况，然后制定个体化的管理计划，并在市政当局进行系统随访，直到 RT 结束后 8 周，由市政护士作为患者的护理协调员进行管理。32 个市政/城市区按照 1:1 的比例随机分为干预组或常规护理组。无论癌症类型、治疗意图和虚弱状态如何，≥65 岁的癌症患者均被纳入并按其居住地区进行分配。主要结局是欧洲癌症研究与治疗组织生活质量问卷核心 30 项（QLQ-C30）测量的身体功能。次要结局是总体生活质量（QoL）、身体机能、卫生服务的使用和费用。分析遵循意向治疗原则。该研究在 ClinicalTrials.gov 注册号 NCT03881137 进行注册。
我们纳入了 178 名患者，每组 89 名，年龄（平均 74.1 岁）、性别（女性 38.2%）和埃德蒙顿虚弱量表评分（平均 3.4[范围 0-17]，评分 0-3[适应]的患者占 57%）具有可比性。更多的干预组患者接受了根治性 RT（76.4%比 61.8%），照射剂量更高（平均 54.1 Gy 比 45.5 Gy），RT 持续时间更长（平均 4.4 周比 3.6 周）。主要结局在 91%（干预组）和 88%（对照组）的患者中完成。两组间预先设定的结局无显著差异。在研究期间，干预组的 GAM 成本占卫生服务总成本的 3%。
在接受 RT 的这一老年患者异质队列中，大多数患者状况良好。我们发现干预措施对以患者为中心的结局或卫生服务成本没有影响。在未来的研究中，强烈建议将目标瞄准更同质的仅有虚弱前期和虚弱的患者群体，以明确 GAM 在 RT 环境中的作用和组织。
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