Kubilay Tolunay Pinar, Erol Cihan, Kahraman Seda, Yildiz Tacar Seher, Özcan Erkan, Bugdayci Basal Fatma, Köse Fatih, Sendur Mehmet Ali Nahit, Tural Deniz, Çiçin Irfan, Öksüzoglu Berna, Kiliçkap Saadettin, Ürün Yüksel
Ankara University Faculty of Medicine, Department of Medical Oncology, Ankara, Turkey.
Ankara Yıldırım Beyazıt University Faculty of Medicine Department of Medical Oncology, Ankara, Turkey.
JAMA Netw Open. 2025 Jan 2;8(1):e2457020. doi: 10.1001/jamanetworkopen.2024.57020.
Clinical trials are vital for advancing cancer treatments and improving patient outcomes. Understanding the factors that influence participants' decision-making is critical for enhancing trial recruitment.
To evaluate the attitudes of patients with cancer and their relatives toward clinical trial participation, identifying key barriers and motivators that affect their willingness to engage in such trials.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional survey study was conducted between April 2020 and April 2021. Face-to-face questionnaires were administered by physicians across 6 tertiary hospital medical oncology departments in Turkey. Adults with cancer and their relatives were recruited. Data were analyzed from April to December 2021.
Participants' knowledge, perceptions, and motivations regarding clinical trial participation were assessed through a structured questionnaire.
Participants' demographic information, their willingness to participate in clinical trials, their perceptions about the clinical trial participation, and the facilitators and barriers to participation.
A total of 978 participants were surveyed, with a median (range) age of 52 (18-82) years; 485 (49.6%) were male and 479 (49.0%) female. Of these, 578 (59.1%) were patients with cancer and 382 (39.1%) family members. Prior clinical trial experience was reported by 174 participants (17.8%), and 428 (43.8%) expressed a willingness to participate in clinical trials. Participants well-informed about clinical trials showed higher willingness (50 of 87 [57.5%] very willing) compared with those with no knowledge (27 of 303 [8.9%] very willing) (χ2 = 275.095; P < .001). Greater willingness was observed in participants from less developed cities compared with the most developed cities (88 of 321 [27.4%] vs 94 of 615 [15.3%]; χ2 = 21.093; P < .001), in individuals with a high school degree or greater compared with those with less than a high school degree (105 of 489 [21.5%] vs 76 of 452 [16.8%]; χ2 = 33.311; P < .001), in those with monthly incomes above compared with below the poverty line (81 of 409 [19.8%] vs 100 of 512 [19.5%]; χ2 = 16.145; P = .003), in those without prior cancer treatment compared with those with prior cancer treatment (125 of 591 [21.2%] vs 40 of 289 [13.8%]; χ2 = 13.801; P = .008), and in participants with prior trial experience compared with those without (74 of 166 [44.6%] vs 111 of 786 [14.1%]; χ2 = 87.771; P < .001). Participants were motivated by potential personal health benefits (604 [61.8%]) and access to new treatments (522 [53.4%]). The primary concerns included potential adverse effects (555 [56.7%]), feeling like a "test subject" (284 [29.0%]), and the risk of receiving a placebo (197 [20.1%]).
In this survey study of patients with cancer and their relatives, significant gaps in knowledge and persistent concerns about clinical trial safety were highlighted, impacting participation. Addressing these concerns through targeted education and transparent communication is essential for improving participation rates and ensuring more inclusive cancer research.
临床试验对于推进癌症治疗和改善患者预后至关重要。了解影响参与者决策的因素对于提高试验招募率至关重要。
评估癌症患者及其亲属对参与临床试验的态度，确定影响他们参与此类试验意愿的关键障碍和动机。
设计、设置和参与者：这项横断面调查研究于2020年4月至2021年4月进行。土耳其6个三级医院医学肿瘤科室的医生进行了面对面问卷调查。招募了成年癌症患者及其亲属。数据于2021年4月至12月进行分析。
通过结构化问卷评估参与者对参与临床试验的知识、认知和动机。
参与者的人口统计学信息、参与临床试验的意愿、对参与临床试验的认知以及参与的促进因素和障碍。
共调查了978名参与者，中位（范围）年龄为52（18 - 82）岁；485名（49.6%）为男性，479名（49.0%）为女性。其中，578名（59.1%）为癌症患者，382名（39.1%）为家庭成员。174名参与者（17.8%）报告有过临床试验经验，428名（43.8%）表示愿意参与临床试验。与不了解临床试验的参与者相比，充分了解临床试验的参与者表现出更高的意愿（87名中有50名[57.5%]非常愿意）（χ2 = 275.095；P <.001）。与最发达城市的参与者相比，欠发达城市的参与者意愿更高（321名中有88名[27.4%] vs 615名中有94名[15.3%]；χ2 = 21.093；P <.001），高中及以上学历的个体比高中以下学历的个体意愿更高（489名中有105名[21.5%] vs 452名中有76名[16.8%]；χ2 = 33.311；P <.001），月收入高于贫困线的参与者比低于贫困线的参与者意愿更高（409名中有81名[19.8%] vs 512名中有100名[19.5%]；χ2 = 16.145；P =.003），未接受过癌症治疗的参与者比接受过癌症治疗的参与者意愿更高（591名中有125名[21.2%] vs 289名中有40名[13.8%]；χ2 = 13.801；P =.008），有过试验经验的参与者比没有试验经验的参与者意愿更高（166名中有74名[44.6%] vs 786名中有111名[14.1%]；χ2 = 87.771；P <.001）。参与者的动机包括潜在的个人健康益处（604名[61.8%]）和获得新治疗方法（522名[53.4%]）。主要担忧包括潜在的不良反应（555名[56.7%]）、感觉像“试验对象”（284名[29.0%]）以及接受安慰剂的风险（197名[20.1%]）。
在这项针对癌症患者及其亲属的调查研究中，突出了知识方面的显著差距以及对临床试验安全性的持续担忧，这影响了参与度。通过有针对性的教育和透明的沟通来解决这些担忧对于提高参与率和确保更具包容性的癌症研究至关重要。
