Supplementary Material for: Assessment of Quality of Life in Postmenopausal Women with Early Breast Cancer Participating in the PACT Trial: The Impact of Additional Patient Information Material Packages and Patient Compliance

<b><i>Background:</i></b> Breast cancer patients’ self-understanding of their disease can impact their quality of life (QoL); the relationship between compliance and QoL is poorly understood. <b><i>Patients and Methods:</i></b> The Patient’s Anastrozole Compliance to Therapy (PACT) program, a prospective, randomized study, investigated the effect of additional patient information material (IM) packages on compliance with adjuvant aromatase inhibitor (AI) therapy in postmenopausal women with hormone receptor-positive early breast cancer. The QoL subanalysis presented here examined the impact of IM packages on QoL and the association between QoL and compliance. European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 questionnaires were completed at baseline, 12 and 24 months, or study termination to assess health-related QoL and disease-related symptoms. <b><i>Results:</i></b> Of the 4,844 patients randomized to standard therapy or standard therapy + IM packages (1:1), 4,253 were available for QoL analysis. No difference in QoL was observed between groups at baseline. IM packages did not have a statistically significant impact on patient QoL at the 12- or 24-month follow-up. Compliant patients experienced improvement in multiple items across the QLQ-C30 and QLQ-BR23 scales at 12 months. However, those results should be interpreted carefully due to limitations in the statistical analyses. <b><i>Conclusions:</i></b> Provision of IM packages did not influence patients’ QoL or satisfaction with care during AI therapy. Compliant patients appear to experience improved QoL compared to noncompliant patients, perhaps indicating a more self-empowered perception of their condition.

背景：乳腺癌患者对自身疾病的自我认知会对其生活质量（Quality of Life, QoL）产生影响，而治疗依从性与生活质量之间的关联目前尚未得到充分阐明。
患者与方法：本研究为前瞻性随机试验——患者阿那曲唑治疗依从性（Patient’s Anastrozole Compliance to Therapy, PACT）项目，旨在探究额外附赠患者信息材料（Information Material, IM）包对激素受体阳性绝经后早期乳腺癌患者接受辅助芳香化酶抑制剂（Aromatase Inhibitor, AI）治疗依从性的影响。本次呈现的生活质量亚分析，旨在评估信息材料包对患者生活质量的作用，以及生活质量与治疗依从性之间的关联。研究采用欧洲癌症研究与治疗组织（European Organization for Research and Treatment of Cancer, EORTC）开发的QLQ-C30与QLQ-BR23问卷，分别于基线、治疗12个月、24个月或研究终止时完成填写，以评估受试者的健康相关生活质量与疾病相关症状。
结果：共计4844例患者按1:1比例被随机分配至标准治疗组与标准治疗+信息材料包组，其中4253例患者可纳入生活质量分析。基线状态下，两组患者的生活质量无显著差异。在12个月或24个月的随访节点，信息材料包未对患者的生活质量产生统计学意义上的显著影响。治疗依从性良好的患者在12个月随访时，QLQ-C30与QLQ-BR23量表的多个条目得分均有所改善，但由于统计分析存在局限性，该结果需谨慎解读。
结论：在芳香化酶抑制剂治疗期间，提供患者信息材料包并未对患者的生活质量或治疗满意度产生影响。与治疗不依从的患者相比，依从性良好的患者生活质量似乎有所提升，这或许提示其对自身病情具备更强的自我掌控感知。