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，远处转移性癌症的人现在寿命更长。然而， 他们的生存需求尚不清楚。很少有研究重点是 患有转移性癌症的人，佐普特（Dospite）越来越认识到他们的支持护理需要不同于 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 研究差距并建立证据基础，以告知多层干预的发展 专为患有转移性癌症患者而设计。我们对这种需求的申请响应 提出一项前瞻性多站点的基于人群的研究，重点是转移性结直肠癌的人 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 有症状的广告事件（Symaes）和与健康相关的生活质量（HRQOL）。我们将研究成年人（年龄） ≥18）被诊断为MCRC，因为它们的数量越来越大，社会人口统计学多样性和显着 症状伯恩从已建立的治疗和新出现的疗法中进行。在先前的MCRC上有所改善 主要侧重于高度选择患者的随机试验的研究，我们将招募参与者 两个基于人群的癌症注册表（新泽西州和大加利福尼亚州），它们的规模被选为 和社会人口统计学多样性。由此产生的数据将更具概括性到现实世界的交付设置 以及居住在MCRC的人的广泛人口。我们将在6-12之内注册1,600个MCRC表面 几个月的诊断，并在基线以及4个，8个月和12个月的随访时间点上进行调查 纵向评估一年多的优点变化。我们将通过信息增强自我报告的数据 从癌症注册表，病历摘要和Medicare索赔数据获得。大多数先前的研究都有 报告了与个人治疗相关的符号的报告，而没有记录相互关联的符号的“簇” 在实践中更常见。因此，在AIM 1中，我们将识别并描述与治疗相关的 物理符号群，然后检查社会人口统计学的变化（例如，年龄，性别，种族，种族，社会性 确定健康）和临床（例如癌症治疗，合并症）因素识别高危的因素 亚组。在AIM 2中，我们将评估Symaes与Pros之间的关系 （即定义总体HRQOL的身体，情感和社会功能）；与癌症有关的财务困扰；和 癌症的社会心理影响。在AIM 3中，我们将探索潜在的干预目标变量。我们将 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。个人级别的目标变量包括用于管理癌症和社会支持的自我效能。 医疗保健系统因素包括护理协调和整合，自付费用以及与 姑息治疗。我们的项目将建立为多层次干预措施提供所需的知识库 改善MCRC患者的症状管理和HRQOL。