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

对患有转移性结直肠癌的成人患者报告的结果进行基于人群的评估

• 批准号: 10711794
• 负责人: Arnold L Potosky
• 金额: $ 76.38万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10711794
• 关键词: Address; Adult; Adverse event; Age; Area; Behavioral Sciences; California; Cancer Survivor; Caring; Characteristics; Chronic; Clinical; Clinical Oncology; Clinical Trials; Colorectal Cancer; Common Terminology Criteria for Adverse Events; Data; Data Reporting; Development; Diagnosis; Disease; Disseminated Malignant Neoplasm; Distant; Distress; Enrollment; Ethnic Origin; Financial Hardship; Fright; Future; Goals; Health Status; Healthcare Systems; Individual; Information Systems; Inpatients; Intervention; Intervention Studies; Knowledge; Life; Link; Longitudinal Studies; Malignant Neoplasms; Measurement; Medical Records; Medicare claim; Neoplasm Metastasis; Neuropathy; New Jersey; Observational Study; Outcome; Pain; Palliative Care; Participant; Patient Outcomes Assessments; Patient Recruitments; Patient Selection; Patient Self-Report; Patients; Persons; Pharmacotherapy; Physical Function; Policies; Population; Population Study; Prevalence; Prospective Studies; Psychometrics; Race; Registries; Reporting; Research; Sampling; Self Efficacy; Self Management; Severities; Site; Sleeplessness; Social Functioning; Social support; Subgroup; Supportive care; Surveys; Survivors; Symptoms; System; Testing; Variant; Work; anticancer research; cancer diagnosis; cancer therapy; care coordination; care costs; care delivery; cohort; comorbidity; cost; design; emotional functioning; evidence base; experience; follow-up; gastrointestinal; health related quality of life; high risk; improved; innovation; integrated care; knowledge base; metastatic colorectal; neoplasm registry; novel therapeutics; population based; prospective; psychosocial; randomized trial; recruit; sex; social health determinants; sociodemographic factors; sociodemographics; survivorship; symptom cluster; symptom management; symptomatic improvement

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.

随着癌症治疗的进步，患有远处转移癌症的人现在寿命更长。 他们的生存需求还没有得到很好的了解。很少有研究关注这一点。 患有转移性癌症的人，尽管人们越来越认识到他们的支持性护理需求不同于 迫切需要进行新的纵向研究来解决这个问题。 研究差距并建立证据基础，为多层次干预措施的制定提供信息 专为患有转移性癌症的人设计，我们的应用程序通过以下方式满足了这一需求。 提出一项以转移性结直肠癌患者为重点的前瞻性多地点人群研究 我们将纵向评估患者报告的结果 (PRO)，包括治疗相关的结果。 我们将研究成人（年龄）的症状不良事件（SymAE）和健康相关生活质量（HRQOL）。 ≥18）被诊断为转移性结直肠癌，因为其数量不断增加、社会人口统计学多样性以及显着的 现有疗法和新兴疗​​法带来的症状负担 改善先前的转移性结直肠癌 (mCRC)。 主要关注精心挑选的患者的随机试验的研究，我们将从 两个基于人口的癌症登记处（新泽西州和大加利福尼亚州），是根据其规模而选择的 和社会人口多样性。由此产生的数据将更适用于现实世界的交付环境。 我们将在 6-12 年内招募 1,600 名 mCRC 幸存者。 诊断后的几个月，并在基线和 4、8 和 12 个月的随访时间点进行调查，以 我们将用信息补充自我报告的数据。 从癌症登记处、医疗记录摘要和医疗保险索赔数据中获得的大多数先前研究。 报告了与个体治疗相关的 SymAE，但没有记录相互相关的 SymAE 的“集群” 因此，在目标 1 中，我们将识别并描述与治疗相关的情况。 身体 SymAE 聚类，然后检查社会人口统计学的变化（例如，年龄、性别、种族、社会 健康的决定因素）和临床（例如癌症治疗、合并症）因素来识别高风险 在目标 2 中，我们将评估 SymAE 和 PRO 之间在 mCRC 中高度显着的关系。 （即定义总体 HRQOL 的身体、情感和社会功能）；以及 在目标 3 中，我们将探索潜在的干预目标变量。 调查个人和医疗保健系统因素是否与更好的 PRO 轨迹相关 个人层面的目标变量包括癌症管理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整合、自付费用以及相关经验 我们的项目将建立为多层次干预提供信息所需的知识库。 改善转移性结直肠癌患者的症状管理和 HRQOL。