McKay Rana, Mills Hannah, Werner Lillian, Choudhury Atish, Choueiri Toni, Jacobus Susanna, Pace Amanda, Polacek Laura, Pomerantz Mark, Prisby Judith, Sweeney Christopher, Walsh Meghara, Taplin Mary-Ellen
University of California San Diego, La Jolla, CA, United States.
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
J Med Internet Res. 2019 May 2;21(5):e12044. doi: 10.2196/12044.
The pace of drug discovery and approvals has led to expanding treatments for cancer patients. Although extensive research exists regarding barriers to enrollment in oncology clinical trials, there are limited studies evaluating processes to optimize patient education, oral anticancer therapy administration, and adherence for patients enrolled in clinical trials. In this study, we assess the feasibility of a video-based, personalized webpage for patients enrolled in genitourinary oncology clinical trials involving 1 or more oral anticancer therapy.
The primary objective of this trial was to assess the differences in the number of patient-initiated violations in the intervention arm compared with a control arm over 4 treatment cycles. Secondary objectives included patient satisfaction, frequently asked questions by patients on the intervention arm, patient-initiated calls to study team members, and patient-reported stress levels.
Eligible patients enrolling on a therapeutic clinical trial for a genitourinary malignancy were randomized 2:1 to the intervention arm or control arm. Patients randomized to the intervention arm received access to a video-based, personalized webpage, which included videos of patients' own clinic encounters with their providers, instructional videos on medication administration and side effects, and electronic versions of educational documents.
A total of 99 patients were enrolled (89 were evaluable; 66 completed 4 cycles). 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.
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.
药物研发和审批的速度促使癌症患者的治疗方法不断增加。尽管关于肿瘤学临床试验入组障碍已有广泛研究，但评估优化患者教育、口服抗癌治疗给药以及临床试验入组患者依从性的流程的研究有限。在本研究中，我们评估了一个基于视频的个性化网页对于参加涉及一种或多种口服抗癌治疗的泌尿生殖系统肿瘤学临床试验患者的可行性。
本试验的主要目的是评估干预组与对照组在4个治疗周期内患者发起的违规数量差异。次要目标包括患者满意度、干预组患者常见问题、患者致电研究团队成员以及患者报告的压力水平。
符合条件并参加泌尿生殖系统恶性肿瘤治疗性临床试验的患者按2:1随机分为干预组或对照组。随机分配到干预组的患者可访问一个基于视频的个性化网页，其中包括患者与医疗服务提供者临床会面的视频、药物给药和副作用的教学视频以及教育文档的电子版。
共招募了99名患者（89名可评估；66名完成4个周期）。总体而言，干预组71%（40/56）的患者有1次或更多次患者发起的违规，而对照组为70%（23/33）。两组在4个周期内违规总数无差异（估计值=-0.0939，95%置信区间-0.6295至0.4418，P值=0.73）。干预组和对照组的基线满意度中位数分别为72和73，表明两组患者满意度都很高。干预组和对照组患者报告的基线压力水平中位数分别为10和13，表明两组在基线时压力水平都较低。
本研究是首批评估基于视频的个性化网页的研究之一，该网页为患者提供教育视频和临床试验预约的视频记录。尽管未达到减少患者发起的违规这一主要终点，但本研究证明了基于视频的个性化网页在临床试验中的可行性。未来评估该工具的研究可能更适合临床试验之外的领域，并可能考虑使用直接评估患者报告结局的终点。本研究的一个主要局限性是缺乏在该人群中估计零假设的先前数据。
