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一个旨在提高肺癌患者临床试验入组率的教育视频。

An educational video to increase clinical trials enrollment among lung cancer patients.

作者信息

Du Wei, Mood Darlene, Gadgeel Shirish, Simon Michael S

机构信息

Carman and Ann Adams Department of Pediatrics, Wayne State University, Children's Hospital of Michigan, 3901 Beaubien, Room 3N47, Detroit, MI 48201, USA.

出版信息

J Thorac Oncol. 2008 Jan;3(1):23-9. doi: 10.1097/JTO.0b013e31815e8bb2.

Abstract

INTRODUCTION

Only 3 to 5% of new adult cancer patients participate in clinical trials nationwide. The lack of knowledge and awareness about clinical trials is a significant barrier to clinical trials participation. A randomized trial was conducted to test the effect of an educational video on positively changing patients' knowledge and attitudes regarding clinical trials and thereby increasing enrollment rates.

METHODS

Lung cancer patients were randomized to viewing either an 18-minute video about clinical trials before first clinic appointment or to standard care. Participants completed a baseline and 2-week postintervention survey to assess their knowledge and attitudes toward trials participation. Fisher's exact test tests, t tests, and regression were used to compare patient characteristics and outcomes between arms.

RESULTS

Of 145 subjects randomized, 126 (63/arm) satisfied all inclusion criteria and were included in the analysis. A linear regression showed that the video intervention was significantly associated with patients' self-assessed likelihood to enroll score measured at 2-week follow-up (p = 0.019). Although statistically insignificant, enrollment rates were found to be higher in the intervention arm for therapeutic trials alone (17.5% versus 11.1%) and for therapeutic and nontherapeutic trials combined (25.4% versus 15.9%).

CONCLUSIONS

The brief educational video seems to be effective in positively changing lung cancer patients' attitudes about participation in clinical trials. Higher enrollment rates were also observed in the intervention group but the differences did not reach statistical significance. These findings suggest a potential impact of the educational video on clinical trial enrollment; however, larger studies are needed to confirm these findings.

摘要

引言

在全国范围内,只有3%至5%的成年癌症新患者参与临床试验。对临床试验缺乏了解和认识是参与临床试验的一个重大障碍。开展了一项随机试验,以测试教育视频对积极改变患者关于临床试验的知识和态度从而提高入组率的效果。

方法

肺癌患者被随机分为两组,一组在首次门诊预约前观看一段18分钟的关于临床试验的视频,另一组接受标准护理。参与者在基线和干预后2周完成一项调查,以评估他们对参与试验的知识和态度。使用Fisher精确检验、t检验和回归分析来比较两组患者的特征和结果。

结果

在145名随机分组的受试者中,126名(每组63名)符合所有纳入标准并被纳入分析。线性回归分析表明,视频干预与患者在2周随访时自我评估的入组可能性得分显著相关(p = 0.019)。虽然在统计学上不显著,但仅在治疗性试验中,干预组的入组率更高(17.5%对11.1%),在治疗性试验和非治疗性试验合并的情况下也是如此(25.4%对15.9%)。

结论

简短的教育视频似乎能有效积极改变肺癌患者对参与临床试验的态度。干预组的入组率也更高,但差异未达到统计学显著性。这些发现表明教育视频对临床试验入组可能有影响;然而,需要更大规模的研究来证实这些发现。

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