Social Determinants of Health in Glioblastoma Population

NCT ID: NCT03900689

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-22
• Study Completion Date: 2022-03-27

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Part 1 Survey Group

Intervention Type: 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 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.

Part 2 Focus Group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy E. Strowd, III, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

WFBCCC 03119

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2019-02214

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00057185

Identifier Type: -

Identifier Source: org_study_id