关键词: clinical trial geriatric assessment phase I

Mesh : Humans Aged Female Male Geriatric Assessment / methods Aged, 80 and over Neoplasms / psychology Clinical Trials, Phase I as Topic Surveys and Questionnaires Cognitive Dysfunction / diagnosis epidemiology psychology Feasibility Studies Mass Screening / methods

来  源:   DOI:10.1002/cnr2.2083   PDF(Pubmed)

Abstract:
BACKGROUND: Though cancer is more prevalent in the older population, this patient group are underrepresented in phase I oncology trials.
OBJECTIVE: We evaluated the use of a geriatric screening tool (SAOP3) in patients of 70 years of age or older who attended a Phase I Clinical Trials Unit, with the aim of assessing the feasibility of the tool and identifying potential unmet needs in this patient group.
METHODS: Twenty-two patients over the age of 70 completed the SAOP3 questionnaire. Geriatric impairments and needs were analysed with descriptive statistics. Qualitative responses were grouped in themes using structured thematic analysis.
RESULTS: All of patients triggered at least 1 geriatric domain, most commonly mobility. Six core themes were identified as being important to the patient including family, friends and positivity. On cognition assessment over 20% of patients triggered as requiring further cognitive assessment. The group had a relatively high screen fail risk.
CONCLUSIONS: In conclusion, routine geriatric screening withSAOP3 was feasible and identified areas of patient need. Results highlight the prevalence of psychological distress and cognitive impairment. Geriatric screening offers an opportunity for prehabilitation prior to trial and support during trial participation to optimise safety and improve trial access.
摘要:
背景:尽管癌症在老年人群中更为普遍,该患者组在I期肿瘤学试验中代表性不足.
目的:我们评估了老年筛查工具(SAOP3)在70岁或以上参加I期临床试验的患者中的使用。目的是评估该工具的可行性,并确定该患者组中潜在的未满足需求。
方法:22名70岁以上的患者完成了SAOP3问卷。用描述性统计分析了老年病的损伤和需求。使用结构化主题分析将定性回答按主题分组。
结果:所有患者都触发了至少1个老年领域,最常见的流动性。六个核心主题被确定为对患者很重要,包括家庭,朋友和积极性。在认知评估中,超过20%的患者被触发为需要进一步的认知评估。该组具有相对较高的屏幕失败风险。
结论:结论:使用SAOP3进行常规老年筛查是可行的,并确定了患者需要的领域。结果突出了心理困扰和认知障碍的患病率。老年筛查为试验前的康复和试验参与期间的支持提供了机会,以优化安全性并改善试验机会。
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