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Social Determinants of Health in Glioblastoma Population

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03900689
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wake Forest University Health Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Roy E. Strowd, III, MD
Principal Investigator Affiliation Wake Forest University Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma, Astrocytoma, Oligodendroglioma, Ependymoma, Ganglioglioma, Pleomorphic Xanthoastrocytoma
Additional Details

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.#46;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.#46;high income communities, by county), by urban vs.#46;rural (urban vs.#46; 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.#46;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.

Arms & Interventions

Arms

: 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.

: 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.

Interventions

Other: - Part 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.

Other: - Part 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

Site Contact

Study Nurse

rstrowd@wakehealth.edu

336-716-7548