Clinical trial NCT03900689: Social Determinants of Health in Glioblastoma Population
Official title: Defining Personal and Communal Aspects of Social Determinants of Health in Glioblastoma Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Astrocytoma
Oligodendroglioma
Ependymoma
Ganglioglioma
Pleomorphic Xanthoastrocytoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a two part, sequential, mixed-methods study. Part 1 will enroll a cross-section of glioma patients at Wake Forest Baptist Comprehensive Cancer Center. In part 2, participants from Part 1 will be identified, selected, and invited to participate.

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.

Eligibility criteria: Inclusion Criteria:

Part 1:

* 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

Part 2:

* 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.

Primary outcomes:
measure: PRAPARE Instrument Questionnaire
timeFrame: Approximately 30 minutes
measure: Accountable Health Communities Health-Related Social Needs Screening Tool
timeFrame: Approximately 30 minutes
measure: Social Determinants of Health Supplementary Questionnaire
timeFrame: Approximately 30 minutes
Secondary outcomes:
measure: Proportion of Social Determinants Based on Two Communities
timeFrame: Approximately 90 minutes
measure: Social Determinants of Health in Participants
timeFrame: Approximately 90 minutes
measure: Social Determinants of Health in Participants' Communities
timeFrame: Approximately 90 minutes
measure: Comparisons of Treatment Timelines Among Low Income and High Income Communities
timeFrame: Approximately 90 minutes
measure: Number of Low Income to High Income Community Participants
timeFrame: Approximately 90 minutes
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Roy E. Strowd, III, MD
role: PRINCIPAL_INVESTIGATOR
References: