UPMC/Jameson Cancer Center, New Castle, PA.
J Oncol Pract. 2011 May;7(3):161-4. doi: 10.1200/JOP.2010.000135.
To investigate the effectiveness of a screening tool to enhance clinical trial participation at a community radiation oncology center involved in a National Cancer Institute-funded disparities program but lacking on-site clinical trials personnel.
The screening form was pasted to the front of the charts and filled out for all new patients over the 9-month period of the study, during which time five external beam radiation therapy (EBRT) trials and a patient perception study were open for accrual. Patient consent was obtained by assorted personnel at several different sites. Patients potentially eligible for a trial were identified and approached by one of the clinic staff. Patients who were under- or uninsured, age > 80 years, members of an racial/ethnic minority, or recipients of medical assistance were identified as at risk for health care disparities and were offered patient navigator services.
Of 196 patients consulted during the study, 144 were treated with EBRT. Of the 24 patients eligible for EBRT trials, 23 were approached (one had an incomplete screening form), and 15 accepted. Of 77 patients eligible for a patient perception trial, 72 were approached (five had incomplete forms), and 45 accepted. The eligibility and acceptance rates for EBRT trials were similar for disparities and nondisparities patients. Screening was completed for 96 patients (67%).
When completed, the screening tool ensured clinical trial accrual. The major factor limiting overall accrual was a shortage of available trials.
调查一种筛选工具在参与美国国立卫生研究院资助的差异项目的社区放射肿瘤中心的有效性,该中心缺乏现场临床试验人员。
在研究的 9 个月期间,将筛选表粘贴到图表的前面,并填写所有新患者的信息。在此期间,有 5 项外部束放射治疗(EBRT)试验和一项患者感知研究正在招募患者。通过几个不同地点的不同人员获得患者同意。由诊所工作人员之一识别和联系可能有资格参加试验的患者。被确定为有健康保健差异风险的患者包括未投保或保险不足、年龄>80 岁、属于少数族裔或接受医疗补助的患者,并为他们提供患者导航服务。
在研究期间咨询的 196 名患者中,有 144 名接受了 EBRT 治疗。在 24 名有资格参加 EBRT 试验的患者中,有 23 名(一名患者的筛选表不完整)被联系,其中 15 名接受了治疗。在 77 名有资格参加患者感知试验的患者中,有 72 名(5 名患者的表格不完整)被联系,其中 45 名接受了治疗。EBRT 试验的合格和接受率在差异和非差异患者中相似。有 96 名患者(67%)完成了筛选。
完成筛选工具后,可确保临床试验的入组。限制整体入组的主要因素是可用试验的短缺。