This trial uses surveys and focus groups to study the personal and communal aspects of social determinants of health in patients with glioblastoma. The purpose of this study is to understand how the conditions in which brain tumor patients are born, grow, live, work, and age affect their response to treatment. These factors are called social determinants of health and include where patients live and work, their prior education and training, access to health insurance, and other factors. This study is being done to describe how these social factors influence patients' health.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03900689.
PRIMARY OBJECTIVES:
I. To describe the social determinants of health in a cross-section of patients with World Health Organization (WHO) grade 2-4 gliomas using a group of validated instruments including the Accountable Health Communities Health-Related Social Needs screening tool (AHC HRSN), a modified version of the Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences (PRAPARE) instrument, and supplementary questions. (Part 1)
II. To identify, compare, contrast, and contextualize the patient- and community-specific social determinants for patients residing in (1) low-income (LIC) and high-income (HIC) zip codes and (2) urban and rural communities. (Part 2)
III. To explore how patients perceive communication with their providers about social and community factors that contribute to health outcomes and understand the barriers, challenges, and opportunities to improve patient-provider communication. (Part 2)
SECONDARY OBJECTIVES:
I. To compare social determinants of health (SDHs) between patients residing in economically disadvantaged and advantaged communities as defined in our prior study (LIC versus [vs] HIC communities, by zip code). (Part 1)
II. To compare SDHs between patients residing in economically disadvantaged and advantaged communities as defined by other means including county (LIC vs HIC community, by county), by urban vs rural (urban vs rural, by city), and by area deprivation index. (Part 1)
III. To quantify and compare the patient- and community-level SDHs present in the cohort and by community (LIC vs HIC). (Part 1)
IV. To compare the time to presentation, time to treatment initiation, and extent of surgery for patients from economically disadvantaged and advantaged communities as described above. (Part 1)
EXPLORATORY OBJECTIVES:
I. To explore associations between SDHs, patient-specific SDHs, and community-level SDHs and the clinical characteristics (e.g. time to presentation), treatments received (e.g. extent of resection, chemoradiation), and outcomes (overall survival). (Part 1)
II. To explore covariates between economic groups, specifically perceived stress, caregiver support, and medical comorbidities influence SDHs and patient outcomes using the Perceived Stress Scale (PSS), Relationship Quality survey, and a comorbidities form. (Part 1)
III. To explore how patients perceive communication from their providers by using the Patient-Centered Communication measurement (PCC). (Part 1)
OUTLINE:
PART I: Patients complete surveys about the social determinants of health over 30 minutes.
PART II: After completion of Part I, patients may optionally participate in a focus group over 60-90 minutes. Caregivers who have had their patient participate in a focus group or telephone interview participate in an interview via video conference of telephone over 60 minutes.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorRoy Ervin Strowd