IMPORTANCE Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can affect patient health-related quality of life (HRQoL). Appropriate information may improve their adherence to treatment and quality of life. OBJECTIVE To evaluate the change in patient's perceptions of the level of information at lanreotide (LAN) treatment initiation for GEP-NETs vs after 6 months. DESIGN OPERA (NCT03562091) was a prospective, longitudinal, noninterventional study. SETTING Thirty-one centers in France specialized in the management of patients with NETs. INTERVENTION Planned clinical visits at enrollment and end-of-study visits at month 6, with completion of the European Organisation for Research and Treatment of Cancer 25-item Quality of Life Questionnaire-Information Module (QLQ-INFO25) and 30-item Quality of Life Questionnaire-Core. MAIN OUTCOME Absolute change in the patient's perception of the information between baseline and month 6, using the relevant domains of the QLQ-INFO25. Endpoints measured at baseline and month 6 for at least 1 of the 3 targeted QLQ-INFO25 dimensions of the primary endpoint. RESULTS Ninety-three of the 115 patients enrolled completed ≥1 primary endpoint information dimension. Mean (SD) scores for the primary endpoint information dimensions were high at baseline (disease, 63.41 [20.71]; treatment, 58.85 [19.00]; supportive care, 26.53 [24.69]; maximum 100). There were no significant changes between baseline (98.34% CI) and 6 months (disease, -2.84 [-8.69, 3.01; P = .24]; treatment, -4.37 [-11.26, 2.52; P = .13]; supportive care, 0.46 [-6.78, 7.70; P = .88]), and in HRQoL between baseline and 6 months. CONCLUSIONS AND RELEVANCE The lack of change in patient's perceptions of the disease, treatment, and supportive care information provided over the first 6 months of LAN treatment may suggest that physicians provided adequate information at the treatment initiation.

中文翻译：

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OPERA：胃肠胰神经内分泌肿瘤患者对兰瑞肽自凝胶的信息感知。

重要性 胃肠胰神经内分泌肿瘤 (GEP-NET) 会影响患者健康相关的生活质量 (HRQoL)。适当的信息可以提高他们对治疗的依从性和生活质量。目的 评估 GEP-NET 兰瑞肽 (LAN) 治疗开始时与 6 个月后相比，患者对信息水平认知的变化。DESIGN OPERA (NCT03562091) 是一项前瞻性、纵向、非干预性研究。设置 法国有 31 个专门从事 NET 患者管理的中心。干预 计划在入组时进行临床访视，并在第 6 个月进行研究结束访视，并完成欧洲癌症研究和治疗组织 25 项生活质量问卷信息模块 (QLQ-INFO25) 和 30 项生活质量问卷生活问卷-核心。主要结果 使用 QLQ-INFO25 的相关领域，患者对基线和第 6 个月信息的感知的绝对变化。在基线和第 6 个月测量主要终点 3 个目标 QLQ-INFO25 维度中至少 1 个的终点。结果 115 名患者中有 93 名完成了≥1 个主要终点信息维度。主要终点信息维度的平均 (SD) 分数在基线时较高（疾病，63.41 [20.71]；治疗，58.85 [19.00]；支持治疗，26.53 [24.69]；最高 100）。基线 (98.34% CI) 和 6 个月之间没有显着变化（疾病，-2.84 [-8.69, 3.01；P = .24]；治疗，-4.37 [-11.26, 2.52；P = .13]；支持治疗, 0.46 [-6.78, 7.70; P = .88])，以及基线和 6 个月之间的 HRQoL。结论和相关性 在 LAN 治疗的前 6 个月内，患者对疾病、治疗和支持性护理信息的看法没有变化，这可能表明医生在治疗开始时提供了足够的信息。