Kehl Kenneth L, Arora Neeraj K, Schrag Deborah, Ayanian John Z, Clauser Steven B, Klabunde Carrie N, Kahn Katherine L, Fletcher Robert H, Keating Nancy L
Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA (KLK, NLK); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (NKA, SBC, CNK); Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA (DS); Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI (JZA); University of California, Los Angeles and RAND Corporation, Santa Monica, CA (KK); Department of Population Medicine (RHF) and Department of Health Care Policy (NLK, JZA), Harvard Medical School, Boston, MA.
J Natl Cancer Inst. 2014 Sep 13;106(10). doi: 10.1093/jnci/dju216. Print 2014 Oct.
Clinical trials are essential to establish the effectiveness of new cancer therapies, but less than 5% of adults with cancer enroll in trials. In addition to ineligibility or lack of available trials, barriers to enrollment may include limited patient awareness about the option of participation.
We surveyed a multiregional cohort of patients with lung or colorectal cancer (or their surrogates) three to six months after diagnosis. We assessed whether respondents reported learning that clinical trial participation might be an option, and, if so, with whom they discussed trials. We used logistic regression to assess the association of patient characteristics with discussing trial participation and enrolling in trials. All statistical tests were two-sided.
Of 7887 respondents, 1114 (14.1%) reported discussing the possibility of clinical trial participation; most learned about trials from their physicians, and 287 patients (3.6% of all patients, 25.8% of trial discussants) enrolled. Among 2173 patients who received chemotherapy for advanced (stage III/IV lung or stage IV colorectal) cancer, 25.7% discussed trials, and 7.6% (29.5% of trial discussants) enrolled. Discussions were less frequent among older patients, African American or Asian vs white patients, and those with lower incomes and more comorbidity. Enrollment was higher among patients reporting shared vs physician-driven decisions (all P < .05).
In this population-based cohort, only 14% of patients discussed participation in clinical trials. Discussions were more frequent among advanced cancer patients but were still reported by a minority of patients. Strategies to expand access to trials and facilitate patient-provider communication about participation may accelerate development of better cancer therapeutics.
临床试验对于确定新型癌症治疗方法的有效性至关重要,但仅有不到5%的成年癌症患者参与试验。除了不符合条件或缺乏可用试验外,参与试验的障碍可能包括患者对参与选项的认知有限。
我们在诊断后三至六个月对一个多地区的肺癌或结直肠癌患者队列(或其代理人)进行了调查。我们评估了受访者是否报告得知参与临床试验可能是一种选择,如果是,他们与谁讨论了试验。我们使用逻辑回归来评估患者特征与讨论试验参与和参与试验之间的关联。所有统计检验均为双侧检验。
在7887名受访者中,1114人(14.1%)报告讨论了参与临床试验的可能性;大多数人从医生那里了解到试验,287名患者(占所有患者的3.6%,占试验讨论者的25.8%)参与了试验。在2173名接受晚期(III/IV期肺癌或IV期结直肠癌)癌症化疗的患者中,25.7%的人讨论了试验,7.6%(占试验讨论者的29.5%)参与了试验。老年患者、非裔美国人或亚裔与白人患者、收入较低且合并症较多的患者中,讨论试验的频率较低。报告共同决策而非医生主导决策的患者参与试验的比例更高(所有P<0.05)。
在这个基于人群的队列中,只有14%的患者讨论了参与临床试验。晚期癌症患者中讨论试验的频率更高,但仍只有少数患者报告。扩大试验可及性并促进患者与提供者关于参与试验的沟通的策略,可能会加速更好的癌症治疗方法的开发。