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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 03119 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| NCI-2019-02214 | Other Identifier | Clinical Trials Reporting Program |
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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.
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Services Research - Part 1 Survey | Participants will be asked to complete a series of surveys. This will be preferentially completed on the same day of the visit but may be completed at a subsequent visit, over the telephone or taken home and sent back to the clinic. |
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| Health Services Research - Part 2 - Focus Group | Patients identified in Part 1 will be offered participation in the focus groups in Part 2. All patients enrolled in Part 1 will be considered for participation in Part 2. Approximately 30 total patients will be invited to participate. Patients who agree to be contacted will receive a telephone call or contacted in clinic and invited to participate in the Part 2 focus group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1 Survey Group | Other | At the first study visit, participants will answer a series of survey questions about their neighborhoods, educational levels, social activities, access to transportation and food, healthcare management and where participants find social and spiritual support. General information such as age, ethnicity and address will also be collected. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Part 1:
Part 2:
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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Roy E. Strowd, III, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2022 | Jun 22, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D004806 | Ependymoma |
| D018303 | Ganglioglioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Part 2 Focus Group | Other | If participants from Part 1 agree to be contacted for Part 2, participants will be included in a focus group to explore unexpected findings and further investigate social determinants identified in Part 1. |
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| 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 |
| 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 |
| 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 |
| 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 |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |