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临床试验/NCT03900689
NCT03900689已完成不适用

Defining Personal and Communal Aspects of Social Determinants of Health in Glioblastoma Population

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Social Determinants of Health Supplementary Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Part 1 Survey Group (Other)

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.

干预措施: Part 2 Focus Group (Other)

结局指标

主要结局

Social Determinants of Health Supplementary Questionnaire

时间窗: 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.

PRAPARE Instrument Questionnaire

时间窗: 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

时间窗: 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.

次要结局

  • Comparisons of Treatment Timelines Among Low Income and High Income Communities(Approximately 90 minutes)
  • Proportion of Social Determinants Based on Two Communities(Approximately 90 minutes)
  • Social Determinants of Health in Participants' Communities(Approximately 90 minutes)
  • Number of Low Income to High Income Community Participants(Approximately 90 minutes)
  • Social Determinants of Health in Participants(Approximately 90 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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