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在合作组临床癌症试验中实施老年评估:CALGB 360401。

Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401.

机构信息

City of Hope, 1500 E Duarte Rd, Duarte, CA 91010, USA.

出版信息

J Clin Oncol. 2011 Apr 1;29(10):1290-6. doi: 10.1200/JCO.2010.30.6985. Epub 2011 Feb 28.

DOI:10.1200/JCO.2010.30.6985
PMID:21357782
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3083997/
Abstract

PURPOSE

Factors captured in a geriatric assessment can predict morbidity and mortality in older adults, but are not routinely measured in cancer clinical trials. This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting.

PATIENTS AND METHODS

Patients age ≥ 65 with cancer, who enrolled on cooperative group cancer trials, were eligible to enroll on Cancer and Leukemia Group B (CALGB) 360401. They completed a geriatric assessment tool before initiation of protocol therapy, consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal resources and time by healthcare providers. The assessment measures functional status, comorbidity, cognitive function, psychological state, social support, and nutritional status. The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance. Patient satisfaction with the tool was captured.

RESULTS

Of the 93 patients who enrolled in this study, five (5%) met criteria for cognitive impairment and three did not complete the cognitive screen, leaving 85 assessable patients (median age, 72 years). The median time to complete the geriatric assessment tool was 22 minutes, 87% of patients (n = 74) completed their portion without assistance, 92% (n = 78) were satisfied with the questionnaire length, 95% (n = 81) reported no difficult questions, and 96% (n = 82) reported no upsetting questions. One hundred percent of health care professionals completed their portion.

CONCLUSION

This brief, primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials.

摘要

目的

老年评估中所捕捉到的因素可以预测老年人的发病率和死亡率,但在癌症临床试验中并未常规测量。本研究评估了在协作组环境中实施老年评估工具的情况。

患者和方法

患有癌症且年龄≥65 岁的患者,在参加合作组癌症试验时,有资格参加癌症和白血病组 B(CALGB)360401。他们在开始协议治疗前完成了一项老年评估工具,该工具由有效的和可靠的老年评估措施组成,主要是自我管理,并且需要医疗保健提供者最少的资源和时间。评估措施包括功能状态、合并症、认知功能、心理状态、社会支持和营养状况。纳入未来合作组试验的工具方案规定的标准是基于完成时间和能够在没有帮助的情况下完成部分评估的患者比例。还捕获了患者对工具的满意度。

结果

在这项研究中,93 名入组患者中有 5 名(5%)符合认知障碍标准,有 3 名患者未完成认知筛查,因此有 85 名可评估患者(中位数年龄为 72 岁)。完成老年评估工具的中位数时间为 22 分钟,87%的患者(n=74)无需帮助即可完成其部分内容,92%(n=78)对问卷长度表示满意,95%(n=81)报告没有困难的问题,96%(n=82)报告没有令人不安的问题。100%的卫生保健专业人员完成了他们的部分内容。

结论

这项简短的、主要是自我管理的老年评估工具符合方案规定的纳入未来合作组临床试验的标准。

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