Aaronson N K, Visser-Pol E, Leenhouts G H, Muller M J, van der Schot A C, van Dam F S, Keus R B, Koning C C, ten Bokkel Huinink W W, van Dongen J A, Dubbelman R
Department of Radiotherapy, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
J Clin Oncol. 1996 Mar;14(3):984-96. doi: 10.1200/JCO.1996.14.3.984.
Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate.
During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed.
The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention.
The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.
我们在此报告一项随机研究的结果，该研究旨在测试一种基于电话的补充护理干预措施在提高患者对要求其参与的临床试验的认识和理解方面的效果。
在12个月期间，180名被邀请参与II期或III期临床试验的癌症患者被随机分为以下两组：（1）基于主治医生的口头解释加书面信息的标准知情同意程序（对照组）；或（2）标准知情同意程序加与肿瘤护士进行的基于电话的补充联系（干预组）。为进行评估，在知情同意程序完成后约1周对所有患者进行了面对面访谈。
两组在社会人口统计学和临床变量方面具有可比性。两组对诊断以及拟进行治疗的性质和目标都有较高的认知水平。干预组在以下方面的了解明显更好（P <.01）：（1）治疗的风险和副作用；（2）治疗的临床试验背景；（3）临床试验的目标；（4）在相关情况下，治疗分配中随机化的使用；（5）替代治疗的可用性；（6）参与的自愿性质；以及（7）退出临床试验的权利。该干预对患者的焦虑水平或临床试验参与率没有任何显著影响。患者对该干预的满意度很高。
使用基于电话的补充护理干预是一种可行且有效的方法，可提高癌症患者对其被要求参与的临床试验所涉及的重要问题的认识和理解。
