Du Wei, Mood Darlene, Gadgeel Shirish, Simon Michael S
Carman and Ann Adams Department of Pediatrics, Wayne State University, Detroit, MI, USA.
Breast Cancer Res Treat. 2009 Sep;117(2):339-47. doi: 10.1007/s10549-009-0311-7. Epub 2009 Jan 17.
Only 3% of women with breast cancer participate in cancer clinical trials nationwide. The lack of awareness about clinical trials is a significant barrier towards clinical trials participation. A study was conducted at a large urban Comprehensive Cancer Center to test (1) the effectiveness of an 18-min educational video on improving attitudes toward clinical trials and trials enrollment among new breast cancer patients seen at the Karmanos Cancer Institute, and (2) to assess racial differences in attitudes regarding clinical trials. Participants were randomized to either the educational intervention prior to their first oncology clinic appointment or to standard care. A baseline and 2-week post-intervention survey to assess attitudes toward clinical trials participation was completed by participants. Of 218 subjects recruited, 196 (55% white vs. 45% African American (AA)) eligible patients were included in the analysis. A small increase in therapeutic clinical trial enrollment was observed in the intervention arm but was not statistically significant (10.4% vs. 6.1%; P = 0.277). The intervention also did not result in a clear improvement in patients' attitudes toward clinical trials at posttest. However, a lower enrollment rate for the AA women was noted after adjusting for stage (OR = 0.282, P = 0.049). Significantly more negative scores were noted in 3 out of the 5 baseline attitudinal scales for AA women. The educational video did not significantly increase enrollment in breast cancer clinical trials. The findings that AA women had significantly more negative attitudes toward clinical trials than white women may partially explain the racial disparity in enrollment. An educational video remains a simple and cost-effective way to educate patients. Future studies should focus on designing a new educational video to specifically target cultural and attitudinal barriers in the AA population to more effectively change attitudes and increase trial enrollment.
在全国范围内,仅有3%的乳腺癌女性患者参与癌症临床试验。对临床试验缺乏认知是阻碍患者参与临床试验的一个重大障碍。在一家大型城市综合癌症中心开展了一项研究,以测试:(1)一段18分钟的教育视频对于改善卡尔马诺斯癌症研究所新确诊乳腺癌患者对临床试验的态度以及参与试验的意愿的有效性;(2)评估对临床试验态度方面的种族差异。参与者被随机分为在首次肿瘤门诊预约前接受教育干预组或接受标准护理组。参与者完成了一项评估参与临床试验态度的基线调查和干预后2周的调查。在招募的218名受试者中,196名符合条件的患者(55%为白人,45%为非裔美国人(AA))纳入分析。在干预组中观察到治疗性临床试验的参与率略有增加,但无统计学意义(10.4%对6.1%;P = 0.277)。干预也未使患者在测试后对临床试验的态度有明显改善。然而,在调整分期后,注意到AA族裔女性的参与率较低(OR = 0.282,P = 0.049)。在AA族裔女性的5个基线态度量表中,有3个量表的负面得分显著更高。该教育视频并未显著增加乳腺癌临床试验的参与率。AA族裔女性对临床试验的负面态度明显多于白人女性这一发现,可能部分解释了参与率方面的种族差异。教育视频仍然是一种简单且经济有效的患者教育方式。未来的研究应专注于设计一种新的教育视频,专门针对AA族裔人群的文化和态度障碍,以更有效地改变态度并提高试验参与率。