Dias A L, Chao J H, Lee D, Wu Y, Kloecker G H
Department of Medicine, Division of Hematology and Medical Oncology, James Graham Brown Cancer Center, 529 S. Jackson Street, Louisville, KY 40202, USA.
Contemp Clin Trials Commun. 2016 Sep 21;4:179-185. doi: 10.1016/j.conctc.2016.09.005. eCollection 2016 Dec 15.
Clinical trials are critical to scientifically evaluate promising new therapies in oncology, but patient accrual to these studies is persistently low. Patient preference plays an important role in enrollment in these trials. We performed this survey to evaluate the perceptions of newly diagnosed oncology patients about clinical trials and the reasons why they wish to or not to participate in these trials.
Patients were given a ten question survey reflective of their attitudes regarding clinical trials as a treatment option at their initial visit. The self-directed questionnaire was scored on an ordinate scale from strongly agree [1] to strongly disagree [5].
Ninety three patients were surveyed in the cancer specific multispecialty clinics in an academic center. Our patients expected their providers to discuss all information relating to clinical trials and eligibility at the first visit (65.4% agree and 15.4% neutral, p < 0.0001). Patients felt their privacy and safety would be safeguarded in the University sponsored trials (56.8% agree, and 25.7% neutral, p < 0.0001). Over 80% patients showed their unwillingness to participate in randomized clinical trials (disagree 61%, neutral 19.5%, p < 0.001). Patients also showed less likelihood to participate in clinical trials as a first treatment option (48.7% disagree and 28.9% neutral, p0.0161), but were willing to consider participating in a clinical trial if the conventional treatment failed. Industry sponsored trials, phase 1 trials, investigator initiated trials with the involved tests and time commitment and altruistic reasons did not significantly deviate from the mean preference analyzed using Fisher's exact test analysis.
Patients consider the option of clinical trials as important in their treatment, and expect to be informed by their oncologist about such trials. Newly diagnosed cancer patients perceive randomization and first line trials negatively. Since randomization data provides new standards of care and hope for improved treatment, patients and their families must be educated of their importance.
临床试验对于科学评估肿瘤学中有前景的新疗法至关重要，但这些研究的患者招募率一直很低。患者偏好在这些试验的入组中起着重要作用。我们开展这项调查以评估新诊断的肿瘤患者对临床试验的看法以及他们希望或不希望参与这些试验的原因。
患者在初次就诊时接受一份包含十个问题的调查问卷，该问卷反映了他们对临床试验作为一种治疗选择的态度。这份自主填写的问卷采用从强烈同意[1]到强烈不同意[5]的纵坐标量表进行评分。
在一个学术中心的癌症专科多学科诊所对93名患者进行了调查。我们的患者期望他们的医疗服务提供者在初次就诊时讨论所有与临床试验及资格相关的信息（65.4%同意，15.4%中立，p<0.0001）。患者认为在大学赞助的试验中他们的隐私和安全将得到保障（56.8%同意，25.7%中立，p<0.0001）。超过80%的患者表示不愿意参与随机临床试验（不同意61%，中立19.5%，p<0.001）。患者作为首选治疗方案参与临床试验的可能性也较小（48.7%不同意，28.9%中立，p0.0161），但如果传统治疗失败，他们愿意考虑参与临床试验。行业赞助的试验、1期试验、研究者发起的试验以及所涉及的检查、时间投入和利他原因，使用Fisher精确检验分析，与平均偏好相比无显著差异。
患者认为临床试验选项在其治疗中很重要，并期望肿瘤学家告知他们此类试验。新诊断的癌症患者对随机分组和一线试验持负面看法。由于随机分组数据提供了新的护理标准和改善治疗的希望，必须让患者及其家属了解其重要性。
