Grant Number:	5R01CA281752-02 Interpret this number
Primary Investigator:	Potosky, Arnold
Organization:	Georgetown University
Project Title:	Population-Based Assessment of Patient-Reported Outcomes in Adults Living with Metastatic Colorectal Cancer
Fiscal Year:	2024

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.





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