GliomaNCT03900689
Social Determinants of Health in Glioblastoma Population
An observational study of Glioma and Astrocytoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Astrocytoma, Oligodendroglioma
- What is being tested?
- Part 1 Survey Group and Part 2 Focus Group
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2019to 27 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
- Women of all races and ethnicity who meet the above-described eligibility criteria are eligible for this trial.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Defining Personal and Communal Aspects of Social Determinants of Health in Glioblastoma Population
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.
Read the detailed description
Part 1:
Primary Objectives
- 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
- 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).
- 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).
- 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).
- 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
- 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.
- 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.
- Conditions
- Glioma, Astrocytoma, Oligodendroglioma, Ependymoma, Ganglioglioma, Pleomorphic Xanthoastrocytoma
- Being tested
- Part 1 Survey Group, Part 2 Focus Group
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma, Ependymoma, Ganglioglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1 Survey GroupOther
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.
Part 2 Focus GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Part 1 Survey Group | |
| 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. Receives: Other: Part 2 Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Approximately 30 minutes
Secondary outcomes (5)
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.
Measured: Approximately 90 minutes
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start22 May 2019
- Primary completion27 Mar 2022
- Study completion27 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roy E. Strowd, III, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900689
- Sponsor's protocol ID
- IRB00057185
- Other IDs
- WFBCCC 03119, NCI-2019-02214
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2019
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Personal and Communal Aspects of Social Determinants of Health in Glioblastoma Population
- ClinicalTrials.gov ID
- NCT03900689
- Acronym / sponsor ID
- IRB00057185
- Conditions
- Glioma, Astrocytoma, Oligodendroglioma, Ependymoma, Ganglioglioma, Pleomorphic Xanthoastrocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 27 Mar 2022 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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).
- 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).
- 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).
- 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
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Services Research - Part 1 Survey | – | Other: Part 1 Survey GroupParticipants 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. |
| Health Services Research - Part 2 - Focus Group | – | Other: Part 2 Focus GroupPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1 Survey GroupAt 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. | Other | Health Services Research - Part 1 Survey |
| Part 2 Focus GroupIf 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. | Other | Health Services Research - Part 2 - Focus Group |
Primary outcome
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.
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.
5 secondary outcomes
Proportion of Social Determinants Based on Two Communities
Time frame: Approximately 90 minutes
Social Determinants of Health in Participants
Time frame: Approximately 90 minutes
Social Determinants of Health in Participants' Communities
Time frame: Approximately 90 minutes
Comparisons of Treatment Timelines Among Low Income and High Income Communities
Time frame: Approximately 90 minutes
Number of Low Income to High Income Community Participants
Time frame: Approximately 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy E. Strowd, III, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Astrocytoma, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRAPARE Instrument Questionnaire (time frame: Approximately 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.