Background The study is based on a national cluster randomized trial investigating the effect of electronic patient-reported outcomes (ePRO) on treatment outcomes in breast cancer patients receiving adjuvant chemotherapy. All 13 oncology departments (11 clusters) treating breast cancer patients in Denmark were randomized to use electronic patient-reported outcomes with real-time clinician feedback (ePRO arm) to track symptoms or usual care for eliciting symptoms using a short paper tracking list (usual care arm). The impact of ePRO on clinical outcomes were examined, which is reported elsewhere. The purpose of the present study was to examine patient-reported experience measure (PREM) regarding communication and handling of side effects/symptoms. Methods For this sub-study, patient representatives were involved in the development of a PREM questionnaire. Patients enrolled in the cluster randomized trial completed the PREM questionnaire at their last treatment visit. Semi-structured telephone-interviews were performed with a subgroup of patients. The interviews were based on an interview guide comprised of the questions from the PREM questionnaire and aimed to elaborate on the PREM questionnaire data. Results A 12 item PREM questionnaire was developed in partnership with patient representatives. In total, 439 out of 682 patients (64.4%) included patients completed the PREM questionnaire. Telephone semi-structured interviews were performed with 22 patients. In total, 52% (ePRO arm) and 65% (usual care arm) reported having talked with the oncologist/nurse about their responses in the tracking systems before each chemotherapy cycle. Fewer patients in the ePRO arm compared to the usual care arm experienced side effects/symptoms not included in the side effect questionnaire. Patients experienced high satisfaction with oncologists' and nurses' handling of side effects/symptoms. Conclusions Patients experienced high satisfaction with oncologists' and nurses' handling of chemotherapy adverse events. The study indicates a need for a more comprehensive side effect questionnaire as tracking system covering more symptoms than the one used in usual care today. Trial registration Clinicaltrials.gov identifier NCT02996201. Registered 19 December 2016, retrospectively registered.

中文翻译：

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接受辅助化疗的乳腺癌患者对症状性不良事件的沟通和处理经验。

背景 本研究基于一项全国性整群随机试验，该试验调查了电子患者报告结果 (ePRO) 对接受辅助化疗的乳腺癌患者治疗结果的影响。在丹麦治疗乳腺癌患者的所有 13 个肿瘤科室（11 个集群）被随机分配使用电子患者报告结果和实时临床医生反馈（ePRO 组）来跟踪症状或使用简短的纸质跟踪列表（通常护臂）。检查了 ePRO 对临床结果的影响，这在其他地方有报道。本研究的目的是检查关于沟通和处理副作用/症状的患者报告经验测量 (PREM)。方法 对于本子研究，患者代表参与了 PREM 问卷的制定。参加整群随机试验的患者在最后一次治疗就诊时完成了 PREM 问卷。对一组患者进行半结构化电话访谈。访谈基于由 PREM 问卷中的问题组成的访谈指南，旨在详细说明 PREM 问卷数据。结果 与患者代表合作开发了一份包含 12 项的 PREM 问卷。总共有 682 名患者中的 439 名（64.4%）完成了 PREM 问卷调查。对 22 名患者进行了电话半结构化访谈。总共，52%（ePRO 组）和 65%（常规护理组）报告说，在每个化疗周期之前，他们与肿瘤科医生/护士讨论了他们在跟踪系统中的反应。与常规护理组相比，ePRO 组中出现副作用调查表中未包含的副作用/症状的患者更少。患者对肿瘤科医生和护士对副作用/症状的处理感到非常满意。结论 患者对肿瘤科医生和护士处理化疗不良事件的满意度较高。该研究表明需要更全面的副作用问卷作为跟踪系统，该系统涵盖的症状比目前常规护理中使用的要多。试验注册 Clinicaltrials.gov 标识符 NCT02996201。2016 年 12 月 19 日注册，追溯注册。与常规护理组相比，ePRO 组中出现副作用调查表中未包含的副作用/症状的患者更少。患者对肿瘤科医生和护士对副作用/症状的处理感到非常满意。结论 患者对肿瘤科医生和护士处理化疗不良事件的满意度较高。该研究表明需要更全面的副作用问卷作为跟踪系统，该系统涵盖的症状比目前常规护理中使用的要多。试验注册 Clinicaltrials.gov 标识符 NCT02996201。2016 年 12 月 19 日注册，追溯注册。与常规护理组相比，ePRO 组中出现副作用调查表中未包含的副作用/症状的患者更少。患者对肿瘤科医生和护士对副作用/症状的处理感到非常满意。结论 患者对肿瘤科医生和护士处理化疗不良事件的满意度较高。该研究表明需要更全面的副作用问卷作为跟踪系统，该系统涵盖的症状比目前常规护理中使用的要多。试验注册 Clinicaltrials.gov 标识符 NCT02996201。2016 年 12 月 19 日注册，追溯注册。和护士对副作用/症状的处理。结论 患者对肿瘤科医生和护士处理化疗不良事件的满意度较高。该研究表明需要更全面的副作用问卷作为跟踪系统，该系统涵盖的症状比目前常规护理中使用的要多。试验注册 Clinicaltrials.gov 标识符 NCT02996201。2016 年 12 月 19 日注册，追溯注册。和护士对副作用/症状的处理。结论 患者对肿瘤科医生和护士处理化疗不良事件的满意度较高。该研究表明需要更全面的副作用问卷作为跟踪系统，该系统涵盖的症状比目前常规护理中使用的要多。试验注册 Clinicaltrials.gov 标识符 NCT02996201。2016 年 12 月 19 日注册，追溯注册。