Population-based assessment of patient-reported outcomes in adults living with metastatic colorectal cancer

随着癌症治疗的进步，患有远处转移癌症的人现在活得更长了。然而， 他们的生存需求并没有得到很好的理解。在中国，很少有关于生存的研究 转移性癌症患者，尽管越来越多的人认识到他们的支持性护理需求与 那些患有早期疾病的人。迫切需要进行新的纵向研究来解决这一问题 研究差距和建立证据基础，为多层次干预的发展提供信息 专为转移性癌症患者设计。我们的应用程序通过以下方式响应这一需求 提出一项以转移性结直肠癌患者为研究对象的前瞻性多点人群研究 癌症(MCRC)。我们将纵向评估患者报告的结果(PRO)，包括与治疗相关的结果 症状不良事件(SymAEs)和健康相关生活质量(HRQOL)。我们将研究成人(年龄 ≥18)被诊断为多发性结直肠癌，因为他们的数量不断增加，社会人口多样性，以及显著的 既有疗法和新出现疗法带来的症状负担。改进以前的mcrc 主要集中在高精选患者的随机试验上的研究，我们将从 两个基于人群的癌症登记(新泽西州和大加利福尼亚州)，这两个登记是根据其规模而选择的 和社会人口多样性。所产生的数据将更加适用于真实世界的交付设置 以及更广泛的mcrc携带者。我们将在6-12年内招收1600名CRC幸存者 几个月的诊断，并在基线和4个月、8个月和12个月的随访时间点对他们进行调查 纵向评估专业人士在一年内的变化。我们将使用信息增强自我报告的数据 从癌症登记处、医疗记录摘要和医疗保险索赔数据中获得。大多数先前的研究都有 报告了与个别治疗相关的SymAE，但没有记录相互关联的SymAE的“集群” 在实践中更常见。因此，在目标1中，我们将确定和描述与治疗相关的 身体症状聚类，然后检查社会人口统计学的变化(例如，年龄、性别、种族-民族、社会 健康决定因素)和临床因素(如癌症治疗、共病)，以确定高危因素 子组。在目标2中，我们将评估SymAE和PRO之间的关系在mCRC中具有非常重要的意义 (即，定义总体HRQOL的身体、情感和社会功能)；与癌症相关的经济困难；以及 癌症的心理社会影响。在目标3中，我们将探索潜在的干预目标变量。我们会 调查个人和医疗保健系统因素是否与更好的PRO轨迹相关 一年。个体水平的目标变量包括管理癌症的自我效能和社会支持。 医疗保健系统因素包括护理协调和集成、自付成本以及以下方面的经验 姑息治疗。我们的项目将建立所需的知识库，为多层次的干预提供信息 改善多发性结直肠癌患者的症状管理和HRQOL。

With advances in cancer treatment, persons with distant metastatic cancer are now living longer. However, their survivorship needs are not well understood. There has been little research focusing on survivorship in persons living with metastatic cancer, despite increased recognition that their supportive care needs differ from those with early-stage disease. There is an urgent need to conduct new longitudinal studies to address this research gap and to build an evidence base for informing the development of multi-level interventions specifically designed for persons living with metastatic cancer. Our application responds to this need by proposing a prospective multi-site population-based study focusing on persons living with metastatic colorectal cancer (mCRC). We will longitudinally assess patient-reported outcomes (PROs) including treatment-related symptomatic adverse events (SymAEs) and health-related quality of life (HRQOL). We will study adults (ages ≥18) diagnosed with mCRC because of their increasing numbers, sociodemographic diversity, and significant symptom burden from established treatments and newly emerging therapies. To improve upon prior mCRC research that focuses primarily on randomized trials of highly selected patients, we will recruit participants from two population-based cancer registries (New Jersey and Greater California), which were chosen for their size and sociodemographic diversity. The resulting data will be more generalizable to real-world delivery settings and the broader population of those living with mCRC. We will enroll 1,600 mCRC survivors within 6-12 months of diagnosis, and survey them at baseline and 4-, 8-, and 12-month follow-up timepoints to longitudinally assess changes in PROs over one year. We will augment self-reported data with information obtained from cancer registries, medical record abstracts, and Medicare claims data. Most prior research has reported on individual treatment related SymAEs, without documenting “clusters” of inter-related SymAEs that are more commonly seen in practice. Therefore, in Aim 1 we will identify and describe treatment-related physical SymAEs clusters, then examine variation by sociodemographic (e.g., age, sex, race-ethnicity, social determinants of health) and clinical (e.g., cancer treatments, comorbidity) factors to identify high-risk subgroups. In Aim 2 we will assess the relationship between SymAEs and PROs highly significant in mCRC (i.e., physical, emotional, and social function that define overall HRQOL); cancer-related financial distress; and psychosocial impacts of cancer. In Aim 3, we will explore potential intervention target variables. We will investigate whether individual and healthcare system factors are associated with better PRO trajectories over one year. Individual-level target variables include self-efficacy for managing cancer and social support. Healthcare system factors include care coordination and integration, out-of-pocket costs, and experiences with palliative care. Our project will build the knowledge base needed to inform multi-level interventions for improving symptom management and HRQOL in persons with mCRC.