ClinicalTrials.gg
CompletedNCT03900689Updated Aug 3, 2026

Social Determinants of Health in Glioblastoma Population

An observational study in Glioma, Astrocytoma and Oligodendroglioma, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Wake Forest University Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Glioma by Wake Forest University Health Sciences — 1 open to participants now, 1 under way, none of them phase 3. Glioma · Wake Forest University Health Sciences.

Started
2019
with 1 other
Observational
4 of 17
none open now
Registered
15th of 17
by date

Among the 17 studies in Glioma by Wake Forest University Health Sciences, this one is one of 2 that started in 2019, is one of 4 observational ones, and was the 15th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

Phase 25 · 0 open
No phase4 · 1 open
Observationalthis study4 · 0 open
Phase 12 · 0 open
Phase 32 · 0 open

By the year they started

First in 2001; this study’s year is marked. 2 started in 2019.

Size and results

Median enrollment 17 across the 12 interventional studies, 37 across the 4 observational. Of the 15 that completed or were terminated, 4 (27%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 17 studies in Glioma by Wake Forest University Health Sciences, or all of them as a file.
02

Study 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 the 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.
03

Conditions studied

  • Glioma
  • Astrocytoma
  • Oligodendroglioma
  • Ependymoma
  • Ganglioglioma
  • Pleomorphic Xanthoastrocytoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Part 1:

  • Adults who are 18 years or older
  • Have a 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

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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Other: Part 2 Focus Group

Interventions

  • OtherPart 1 Survey Group

    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.

  • OtherPart 2 Focus Group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 30 minutes

  2. 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.

    Time frame: Approximately 30 minutes

  3. 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.

    Time frame: Approximately 30 minutes

Secondary outcomes

  1. 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.

    Time frame: Approximately 90 minutes

  2. 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.

    Time frame: Approximately 90 minutes

  3. 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.

    Time frame: Approximately 90 minutes

  4. 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.

    Time frame: Approximately 90 minutes

  5. 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.

    Time frame: Approximately 90 minutes

07

Study locations

1 site
  • Wake Forest Baptist Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2019 to primary completion in Mar 2022, 34 months.

Of 113 non-industry observational studies under Glioma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 104. This study's 34 months is below that.

Counting every sponsor, half of 123 studies reached it within 60 months; a quarter within 29 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2019
First posted
Apr 3, 2019
StartActual
May 22, 2019
Primary completionActual
Mar 27, 2022
CompletionActual
Mar 27, 2022
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03900689
Responsible party
Sponsor
First posted
Apr 3, 2019
Start date
May 22, 2019
Primary completion
Mar 27, 2022
Completion
Mar 27, 2022
Last update
Aug 3, 2026

Study contacts

Roy E. Strowd, III, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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