TY - JOUR AU - McKay, Rana AU - Mills, Hannah AU - Werner, Lillian AU - Choudhury, Atish AU - Choueiri, Toni AU - Jacobus, Susanna AU - Pace, Amanda AU - Polacek, Laura AU - Pomerantz, Mark AU - Prisby, Judith AU - Sweeney, Christopher AU - Walsh, Meghara AU - Taplin, Mary-Ellen PY - 2019 DA - 2019/05/02 TI -在泌尿生殖肿瘤临床试验中评估基于视频的个性化网页:2期随机试验JO - J Med Internet Res SP - e12044 VL - 21 IS - 5kw -癌症KW -前列腺肿瘤KW -肾肿瘤KW -临床试验KW -教学电影和视频KW -教育AB -背景:药物发现和批准的速度导致了对癌症患者的治疗扩大。虽然有大量关于肿瘤临床试验登记障碍的研究，但评估优化患者教育、口服抗癌治疗给药和临床试验登记患者依从性的过程的研究有限。在这项研究中，我们评估了一个基于视频的个性化网页的可行性，用于参与泌尿生殖肿瘤临床试验的患者，包括1种或多种口服抗癌疗法。目的:本试验的主要目的是评估干预组与对照组在4个治疗周期内患者引发的违规行为数量的差异。次要目标包括患者满意度、患者在干预组的常见问题、患者主动给研究团队成员的电话以及患者报告的压力水平。方法:纳入泌尿生殖系统恶性肿瘤治疗性临床试验的符合条件的患者被随机2:1分为干预组和对照组。随机分配到干预组的患者可以访问一个基于视频的个性化网页，其中包括患者与他们的提供者在诊所遇到的视频，关于药物管理和副作用的教学视频，以及教育文件的电子版本。结果:共纳入99例患者(89例可评估;66完成4个周期)。 In total, 71% (40/56) of patients in the intervention arm had 1 or more patient-initiated violation compared with 70% (23/33) in the control arm. There was no difference in the total number of violations across 4 cycles between the 2 arms (estimate=−0.0939, 95% CI−0.6295 to 0.4418, P value=.73). Median baseline satisfaction scores for the intervention and control arms were 72 and 73, respectively, indicating high levels of patient satisfaction in both arms. Median baseline patient-reported stress levels were 10 and 13 for the intervention and control arms, respectively, indicating low stress levels in both arms at baseline. Conclusions: This study is among the first to evaluate a video-based, personalized webpage that provides patients with educational videos and video recordings of clinical trial appointments. Despite not meeting the primary endpoint of reduced patient-initiated violations, this study demonstrates the feasibility of a video-based, personalized webpage in clinical trials. Future research assessing this tool might be better suited for realms outside of clinical trials and might consider the use of an endpoint that assesses patient-reported outcomes directly. A major limitation of this study was the lack of prior data for estimating the null hypothesis in this population. SN - 1438-8871 UR - //www.mybigtv.com/2019/5/e12044/ UR - https://doi.org/10.2196/12044 UR - http://www.ncbi.nlm.nih.gov/pubmed/31045501 DO - 10.2196/12044 ID - info:doi/10.2196/12044 ER -