ImportanceClinical trials are critical for progress in oncology; however, only 5% of the adult cancer population participates. Harnessing data that are routinely collected (ie, electronic patient-reported outcomes [ePROs]) may serve as a method to promote trial enrollment.ObjectiveTo evaluate if an ePRO-prompted recruitment strategy is associated with increased clinical trial enrollment.Design, Setting, and ParticipantsA randomized substudy was conducted from September 2022 to March 2023 at a multisite tertiary cancer center as part of an ongoing clinical trial that was testing a symptom-intervention for cancer-related fatigue. Patients with breast cancer who were undergoing radiotherapy who completed at least 1 ePRO questionnaire during the study period were included. Physician-level cluster randomization assigned fatigue-eligible patients to either receive a portal message invitation to a symptom-intervention trial or standard of care (SOC; physician-based referral).ExposureePRO questionnaires distributed in routine practice were queried weekly and screened for moderate or greater fatigue, the principle inclusion criterion for the primary trial. To assess the association of the portal message source with response and enrollment, every other patient received a message from the primary radiation oncology team or the referral service.Main Outcomes and MeasuresClinical trial response/referral and enrollment.ResultsA total of 1041 patients completed ePRO questionnaires, of whom 394 (38%; 53 Asian [13.6%], 43 Black [11.0%], 29 Hispanic [7.4%], and 262 White individuals [66.5%]; median [IQR] age, 55 [47-65] years) endorsed moderate or greater fatigue while receiving treatment. A total of 210 patients (53.3%) were assigned to receive a portal message and 184 (46.7%) patients, SOC. In the portal message group, 73 patients (35%) responded and 41 (20%) enrolled compared with 1 patient (0.5%) referred and 0 enrolled in the SOC group (P < .001). The response rate to portal messages favored the referral service vs the primary radiation oncology service (44% vs 26%; P = .01), but there was no significant difference in enrollments.Conclusions and RelevanceThe study results suggest that use of routine care ePROs was associated with greater enrollment in a symptom-intervention trial compared with physician-based referral. Messaging directly from the referral service may support enrollment and help reduce oncology physician-level barriers to trial enrollment for studies testing symptom interventions.

中文翻译：

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患者报告的结果作为临床试验注册的招募策略

重要性临床试验对于肿瘤学的进展至关重要；然而，只有 5% 的成人癌症人口参与。利用常规收集的数据（即电子患者报告结果 [ePRO]）可以作为促进试验注册的一种方法。目的评估 ePRO 提示的招募策略是否与增加临床试验注册相关。设计、设置和参与者 2022 年 9 月至 2023 年 3 月在一个多地点三级癌症中心进行了一项随机亚组研究，作为正在进行的临床试验的一部分，该试验正在测试癌症相关疲劳的症状干预措施。纳入研究期间至少完成 1 份 ePRO 问卷且正在接受放射治疗的乳腺癌患者。医生级别的整群随机化分配符合疲劳条件的患者接受症状干预试验或标准护理（SOC；基于医生的转诊）的门户消息邀请。每周查询在常规实践中分发的 ExposureePRO 调查问卷，并筛选中度或更大的疲劳，初步试验的原则纳入标准。为了评估门户消息源与响应和入组的关联，其他所有患者均收到来自初级放射肿瘤学团队或转诊服务的消息。主要结果和措施临床试验响应/转诊和入组。结果共有 1041 名患者完成了 ePRO 问卷，其中 394 名（38%；53 名亚裔 [13.6%]、43 名黑人 [11.0%]、29 名西班牙裔 [7.4%] 和 262 名白人 [66.5%]；中位 [IQR] 年龄为 55 [47-65]年）认可在接受治疗时出现中度或重度疲劳。共有 210 名患者 (53.3%) 被分配接收门户消息，184 名患者 (46.7%) 被分配为 SOC。在门户消息组中，73 名患者 (35%) 做出回应，41 名患者 (20%) 入组，而 SOC 组有 1 名患者 (0.5%) 转介，0 名患者入组（磷< .001）。与主要放射肿瘤学服务相比，对门户消息的响应率更倾向于转诊服务（44% vs 26%；磷= .01），但登记人数没有显着差异。结论和相关性研究结果表明，与基于医生的转诊相比，使用常规护理 ePRO 与症状干预试验的登记人数增加相关。直接来自转诊服务的消息可以支持注册，并有助于减少肿瘤科医生在测试症状干预研究的试验注册方面的障碍。