Soubeyran Pierre, Terret Catherine, Bellera Carine, Bonnetain Franck, Jean Olivier Saint, Galvin Angéline, Chakiba Camille, Zwolakowski Marie-Dominique, Mathoulin-Pélissier Simone, Rainfray Muriel
Department of Medical Oncology, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.
University of Bordeaux, F-33000, Bordeaux, France.
BMC Cancer. 2016 Dec 1;16(1):932. doi: 10.1186/s12885-016-2927-4.
In the general geriatric population, programs linking geriatric evaluation with interventions are effective for improving functional status and survival of the patients. Whether or not these interventions improve health related quality of life (HRQoL) or overall survival (OS) in older patients with cancer is not yet clear. Indeed, randomized data on the effect of such interventions on survival and HRQoL are rare and conflicting. We describe the rationale and design of a phase III multicenter trial aimed at assessing the efficacy of geriatric intervention in the management of elderly patients with cancer.
METHODS/DESIGN: Approximately 1200 patients, 70 years and older, considered in need of a geriatric intervention based on the G8 screening tool will be randomized into two intervention arms. The 'Usual-care' arm involves standard oncological care based on pre-defined oncological protocols. In addition to the standard oncological care, the 'Case-management' arm involves a multidimensional geriatric assessment and interventions tailored for the patient. Efficacy will be assessed using a co-primary endpoint encompassing OS and HRQoL.
This trial has been designed to assess whether focused geriatric case management can either improve OS or HRQoL in elderly cancer patients considered in need of geriatric assessment.
Clinicaltrials.gov ID: NCT02704832 .
在一般老年人群中，将老年评估与干预措施相结合的项目对于改善患者的功能状态和生存率是有效的。这些干预措施是否能改善老年癌症患者的健康相关生活质量（HRQoL）或总生存期（OS）尚不清楚。实际上，关于此类干预措施对生存率和HRQoL影响的随机数据很少且相互矛盾。我们描述了一项旨在评估老年干预措施在老年癌症患者管理中疗效的III期多中心试验的基本原理和设计。
方法/设计：根据G8筛查工具，约1200名70岁及以上且被认为需要老年干预的患者将被随机分为两个干预组。“常规护理”组采用基于预定义肿瘤学方案的标准肿瘤护理。除标准肿瘤护理外，“病例管理”组还包括针对患者的多维老年评估和干预措施。疗效将使用包括OS和HRQoL的共同主要终点进行评估。
本试验旨在评估针对性的老年病例管理是否能改善被认为需要老年评估的老年癌症患者的OS或HRQoL。
Clinicaltrials.gov标识符：NCT02704832 。
