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Clinical Trials/NCT03900689
NCT03900689
Completed
N/A

Defining Personal and Communal Aspects of Social Determinants of Health in Glioblastoma Population

Wake Forest University Health Sciences1 site in 1 country100 target enrollmentMay 22, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Glioma
Sponsor
Wake Forest University Health Sciences
Enrollment
100
Locations
1
Primary Endpoint
Social Determinants of Health Supplementary Questionnaire
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The overall aim of this study is to prospectively characterize social health disparities in a cross-sectional cohort of glioma patients with attention to exploring and thematically categorizing the patient-specific and community-level factors. This will be conducted in two parts.

Detailed Description

Part 1: Primary Objectives 1. To describe the social determinants of health in a cross-section of patients with WHO Grade 2-4 gliomas using a group of validated instruments including the PRAPARE instrument, the Accountable Health Communities Health-Related Social Needs Screening Tool (AHC HRSN), and supplementary questions. Secondary Objectives 1. To compare social determinants of health between patients residing in economically disadvantaged and advantaged communities as defined in our prior study (low income communities vs high income county communities, by zip code). 2. To compare social determinants of health between patients residing in economically disadvantaged and advantaged communities as defined by other means including county (low income communities vs high income communities, by county), by urban vs rural (urban vs rural, by city), and by area deprivation index (see Section 5.2). 3. To quantify and compare the patient- and community-level social determinants of health present in the cohort and by community (low income community vs high income community). 4. 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 2: Data from our preliminary study revealed differences in survival for patients from low income communities compared to high income community zip codes. The overarching goal of Part 2 is to further characterize the social factors that characterize low income community and high income communities and may contribute to the differences in outcome. Primary Aim 1. To identify, compare, contrast, and contextualize the patient- and community-specific social determinants for patients residing in (1) low income communities and high income community zip codes and (2) urban and rural communities. 2. 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.

Registry
clinicaltrials.gov
Start Date
May 22, 2019
End Date
March 27, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults who are 18 years or older
  • Have a histologically confirmed glioma of any grade (WHO Grade 2-4: astrocytoma, oligodendroglioma, ependymoma, ganglioglioma, pleomorphic xanthroastrocytoma)
  • Currently receiving primary oncologic care at Wake Forest Baptist Comprehensive Cancer Center
  • Have the ability to speak and read either English or Spanish.
  • Ability to provide informed consent
  • Participants who participated in Part 1 and express willingness to be contacted about Part 2
  • Ability to provide informed consent
  • Ability to speak and understand English
  • Inclusion of Women and Minorities (for Part 1 and Part 2)
  • Women of all races and ethnicity who meet the above-described eligibility criteria are eligible for this trial.

Exclusion Criteria

  • Patients who are unable to read or complete the required study-related forms. Patients who are unable to read but can be assisted by a proxy or family member will be included.

Outcomes

Primary Outcomes

Social Determinants of Health Supplementary Questionnaire

Time Frame: Approximately 30 minutes

The questionnaire is composed of 5 sections (economic status, social and community context, neighborhood and environment, health and healthcare and education) and has a combination of Yes or No questions, multiple choice questions, and Likert questions (never to always). This will be completed in Part 1 of the study.

PRAPARE Instrument Questionnaire

Time Frame: Approximately 30 minutes

A 21 question questionnaire to collect data based on five main social determinants of health (education, economic status, neighborhood/surrounding environment, health and healthcare, community involvement). The questionnaire is comprised of Yes or No answers, multiple choice questions and Likert scale questions (not at all to quite a bit). This will be completed in Part 1 of the study.

Accountable Health Communities Health-Related Social Needs Screening Tool

Time Frame: Approximately 30 minutes

An 18 question screening tool to help find out participants' needs in areas of housing instability, food insecurity, utility help needs, financial status, family and community support and physical activity. The questionnaire is comprised of Yes or No answers, multiple choice questions and Likert scale questions (Not hard at all to very hard; never to often). This will be completed in Part 1 of the study.

Secondary Outcomes

  • Comparisons of Treatment Timelines Among Low Income and High Income Communities(Approximately 90 minutes)
  • Proportion of Social Determinants Based on Two Communities(Approximately 90 minutes)
  • Social Determinants of Health in Participants' Communities(Approximately 90 minutes)
  • Number of Low Income to High Income Community Participants(Approximately 90 minutes)
  • Social Determinants of Health in Participants(Approximately 90 minutes)

Study Sites (1)

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