Effect of the HCC Liver-Link Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Time to waitlist
研究概览
简要总结
This study is a pilot, multi-center randomized controlled trial testing the HCC Liver-Link intervention, a culturally tailored, multi-level program designed to reduce racial disparities in hepatocellular carcinoma (HCC) care. The intervention combines: (1) patient education to improve HCC-related disease and treatment knowledge, (2) social needs and substance use screening with referral to social work and community resources, and (3) facilitated access to subspecialty cancer care through a multidisciplinary HCC tumor board.
A total of 40 Black patients with Barcelona Clinic Liver Cancer (BCLC) stage 0, A, or downstaged B disease will be randomized to receive either the HCC Liver-Link intervention or usual care and followed for 6 months or until liver transplant waitlisting. Primary outcomes are time to receipt of curative therapies (liver transplantation or resection) and change in HCC-related knowledge. Findings will inform development of larger interventions to eliminate racial disparities in HCC outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be randomized on a 1:1 basis, stratified by race and SES. NIH randomization tool will be used to randomize patients into status of care and intervention arms.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within UCSF criteria:
- •Candidates are eligible or a standardized MELD or PELD exception if, before completing locoregional therapy, they have lesions that meet one of the following criteria:
- •One Class 5 lesion greater than 5 cm and less than or equal to 8 cm
- •two or three Class 5 lesions that meeting all of the following
- •At least one lesion greater than 3cm
- •Each lesion less than or equal to 5 cm, and
- •A total diameter of all lesions less than or equal to 8cm
- •Four or five Class 5 lesions each less than 3 cm, and a total diameter of all lesions less than or equal to 8 cm.
- •Between 18-75 years old
- •Have no more than two visits with an HCC-related provider
- •Able to read, write, and speak English
- •Any 1 of the following:
- •Self-report as Black race (can be multiple races as long as 1 is Black)
- •Self-report as insured by Medicaid (+/- Medicare)
- •SVI (Social vulnerability index) >= .75
- •Unmarried
排除标准
- •Lacks capacity to provide informed consent, including those with stage 2 HE or higher at the time of consent.
- •Age over 75
- •Last transthoracic echocardiogram with EF<40% (OK if no prior echo)
- •BMI over 50
- •Patients who, in the investigator's judgment, are unlikely to ever be eligible for liver transplantation or resection at the time of enrollment, with reason documented
- •Prior history of any solid organ transplant
- •Non-skin cancer malignancies other than hepatocellular carcinoma in past 2 years unless approved by PI (i.e. cervical cancer, early prostate cancer)
- •Patients who have undergone resection or waitlisted
- •Patients near completion of transplant evaluation, PI to determine utility of intervention.
研究组 & 干预措施
Liver-Link Arm
Those randomized to the Liver-Link portion of the study will proceed through the Liver-Link component intervention. Participation in this study will last 6 months. Participants in this group are assessed for knowledge of their disease, quality of life, substance use, and for social needs at the beginning of the program. Those who screen positive for social needs or high-risk alcohol will see social work. Participants will attend 3 support groups and compelte exit surveys. Participants will have 3 milestone checks during the 6 month study period and will be referred back to social work if they do not meet milestones. Participants will also have a knowledge assessment after a total of 2 HCC-related visits.
干预措施: Liver Link (Other)
Standard of Care Arm
Individuals in the standard of care portion of the study will complete several questionnaires at the enrollment visit . Over the duration of study participation (6 months), participants in this arm may meet with a social worker as part of their standard health care treatment and will receive education via these standard of care visits. After at least two visits related to HCC clinical care, and participants in this arm will be contacted and will be asked to complete the knowledge assessment tool. At tne end of study they will complete exit survieys via redcap or phone.
结局指标
主要结局
Time to waitlist
时间窗: Up to 6 months post-enrollment
Days from study enrollment to liver transplant waitlisting, assessed using OTTR.
Time to resection
时间窗: Up to 6 months post-enrollment
Days from study enrollment to surgical resection, assessed using EMR.
Waitlisting or Resection
时间窗: Up to 6 months post-enrollment
Proportion of participants who achieve liver transplant waitlisting or surgical resection, assessed using EMR and OTTR
Time to Death
时间窗: Up to 12 months post-enrollment.
Days from study enrollment to death, assessed using EMR and OTTR.
次要结局
- HCC-Related Knowledge(Baseline and 6 months post-enrollment.)
- Medical Mistrust(Baseline and 6 months post-enrollment.)
- Social Needs and AUD Linkage(Up to 6 months post-enrollment.)
- Quality of Life (QOL)(Baseline and 6 months post-enrollment.)
研究者
Lauren Nephew
Assistant Professor | Division of Gastroenterology & Hepatology| IU School of Medicine |IU Health Associate Vice Chair of Health Equity| IU School of Medicine | IU Health
Indiana University