Perceptions of participation in a phase I, II, or III clinical trial among African American patients with cancer: what do refusers say?
Perceptions of participation in a phase I, II, or III clinical trial among African American patients with cancer: what do refusers say?
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DOI：
10.1200/jop.2013.001039
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发表时间：
2013-11
影响因子：
--
通讯作者：
Siminoff LA
中科院分区：
文献类型：
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作者：
Brown RF;Cadet DL;Houlihan RH;Thomson MD;Pratt EC;Sullivan A;Siminoff LA
不到 5% 的成年癌症患者进入临床试验。这些比率在少数种族/族裔人群中较低，对试验结果的普遍性和有效性产生负面影响。许多研究都发现了少数族裔入组的障碍，但很少有研究深入了解少数族裔患者拒绝试验的原因。我们的目的是 (1) 以拒绝参加试验的非裔美国人 (AA) 癌症患者为样本，探讨拒绝试验的原因；(2) 收集患者对一系列决策支持工具的潜在益处的看法。参与者是连续招募的 22 名 AA 癌症患者，他们拒绝参加治疗性临床试验。在试验拒绝决定后 3 个月内，参与者完成了录音半结构化访谈，询问人口和疾病信息、心理社会因素以及患者对临床试验的体验。两个月后，参与者完成了一份调查问卷，询问他们的试验决定。很少有患者收到关于参加试验的积极建议。患者给出了多种拒绝理由。只有两名参与者因不信任问题而拒绝参加临床试验。大多数参与者因担心额外负担和不利影响而拒绝。许多患者和家属误解了试验信息。家属大多建议不参加试验。大多数患者认为问题提示列表或决策辅助工具将有助于信息查找和决策。医生建议 AA 癌症患者参与临床试验的比例较低，值得进一步调查。在临床互动的内部和外部，减少误解和帮助决策的干预措施需要针对患者和家庭成员。
Less than 5% of all adult patients with cancer enter clinical trials. These rates are lower in racial/ethnic minority populations, negatively affecting the generalizability and validity of trial results. Many studies have identified barriers to minority enrolment, yet few have gathered in-depth insights into minority patients’ reasons for trial refusal. We aimed to (1) explore trial refusal reasons in a sample of African American (AA) patients with cancer who declined trial participation and (2) gather patients’ perceptions of the potential benefit of an array of decision support tools. Participants were 22 consecutively recruited AA patients with cancer who had declined participation in a therapeutic clinical trial. Within 3 months of the trial refusal decision, participants completed an audio-recorded semistructured interview that asked about demographic and disease information, psychosocial factors, and patients’ experience with clinical trials. Two months later, participants completed a questionnaire that asked about their trial decision. Few patients received positive recommendations about joining a trial. Patients gave multiple refusal reasons. Only two participants refused to join a clinical trial as a result of issues of mistrust. Most participants refused as a result of fears of additional burdens and adverse effects. Many patients and family members misunderstood trial information. Family members mostly recommended against trial participation. Most patients felt that question prompt lists or decision aids would assist information seeking and decision making. Low rates of physician recommendations for clinical trial participation of AA patients with cancer warrant further investigation. Interventions to reduce misunderstandings and aid decision making, both within and external to the clinical interaction, need to target both patients and family members.