Glioma Clinical Trial
Official title:
Defining Personal and Communal Aspects of Social Determinants of Health in Glioblastoma Population
Verified date | December 2023 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 27, 2022 |
Est. primary completion date | March 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PRAPARE Instrument Questionnaire | 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. | Approximately 30 minutes | |
Primary | Accountable Health Communities Health-Related Social Needs Screening Tool | 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. | Approximately 30 minutes | |
Primary | Social Determinants of Health Supplementary Questionnaire | 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. | Approximately 30 minutes | |
Secondary | Proportion of Social Determinants Based on Two Communities | Social determinants of health between participants residing in economically disadvantaged and advantaged communities (defined by zip codes) will be compared by comparing responses to questionnaires for these two populations based on the residential zip codes. This will be conducted during Part 2 of the study. | Approximately 90 minutes | |
Secondary | Social Determinants of Health in Participants | Patient-specific factors will be quantified using the PRAPARE instrument, the Accountable Health Communities Health-Related Social Needs Screening Tool, and supplemental questions data collected from Part 1 of the study to compare social determinants of health among participants. This will be conducted during Part 2 of the study. | Approximately 90 minutes | |
Secondary | Social Determinants of Health in Participants' Communities | Community-specific factors will be quantified using the PRAPARE instrument, the Accountable Health Communities Health-Related Social Needs Screening Tool, and supplemental questions data collected from Part 1 of the study to compare social determinants of health within the participants' communities. This will be conducted during Part 2 of the study. | Approximately 90 minutes | |
Secondary | Comparisons of Treatment Timelines Among Low Income and High Income Communities | Time to presentation, treatment initiation, and extent of surgery for patients will be obtained from Wake Forest Baptist Comprehensive Cancer Center Registry and compared based on economically disadvantaged and advantaged communities. | Approximately 90 minutes | |
Secondary | Number of Low Income to High Income Community Participants | Participants will be categorized as coming from a low income community of high income community zip code through use of the CDC census data that details median household income for the zip codes provided by participants. | Approximately 90 minutes |
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