Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Number of Days to First Contact
研究概览
简要总结
The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HCC Patients:
- •Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma.
- •Diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and International Classification of Diseases, Tenth Revision (ICD-10) C22.
- •Adults, age 18 or older
- •Able to provide informed consent
- •All other interviewees:
- •Advocates who will self-identify as having had HCC.
- •Others who self-identify as either a caregiver or support person of an HCC patient.
- •Physicians/Licensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients.
排除标准
- •Unable to speak Spanish or English
- •West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment.
- •Adults unable or unwilling to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Prisoners
- •Given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected
研究组 & 干预措施
Aim 3: Targeted Navigation Pilot Program
Participants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months.
干预措施: Target Navigation Pilot Program (Behavioral)
结局指标
主要结局
Number of Days to First Contact
时间窗: Up to 12 months
The time to first contact since hepatocellular carcinoma diagnosis will be assessed in number of days.
Number of Hours for Each Contact
时间窗: Up to 12 months
The length of time of each contact will be assessed in number of hours. Contact is defined as the length of time the navigator meets with the participant.
Number of Days to First Appointment
时间窗: Up to 12 months
The time to first appointment will be assessed in number of days.
Number of Days to First Treatment
时间窗: Up to 12 months
The time to first treatment will be assessed in number of days.
Number of Months of Total Navigation
时间窗: Up to 12 months
The length of total navigation will be assessed in number of months.
Number of Participants that Die Within One Year
时间窗: Up to 1 year
Number of participants that die within one year of enrollment in the navigation program.
Proportion of Participants Enrolled in Clinical Research
时间窗: Up to 12 months
The proportion of participants enrolled in clinical research will be reported.
Acceptability
时间窗: Enrollment
Percentage of approached individuals who agree to participate
次要结局
未报告次要终点
研究者
Patricia Jones, MD
Associate Professor of Clinical Medicine
University of Miami