Social Determinants of Health in Glioblastoma Population

NCT03900689 | Completed DMC

• 3 other identifiers: IRB00057185WFBCCC 03119NCI-2019-02214
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Astrocytoma; Oligodendroglioma; Ependymoma; Ganglioglioma; Pleomorphic Xanthoastrocytoma

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Proportion of Social Determinants Based on Two Communities

  Approximately 90 minutes

• Social Determinants of Health in Participants

  Approximately 90 minutes

• Social Determinants of Health in Participants' Communities

  Approximately 90 minutes

• Comparisons of Treatment Timelines Among Low Income and High Income Communities

  Approximately 90 minutes

• Number of Low Income to High Income Community Participants

  Approximately 90 minutes

Study Arms (2)

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

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.

Health Services Research - Part 1 Survey

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.

Health Services Research - Part 2 - Focus Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Women of all races and ethnicity who meet the above-described eligibility criteria are eligible for this trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Glioma; Astrocytoma; Oligodendroglioma; Ependymoma; Ganglioglioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Roy E. Strowd, III, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: May 22, 2019
• Primary Completion: March 27, 2022
• Study Completion: March 27, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)