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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MD018090 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver-Link Arm | Experimental | 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. |
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| Standard of Care Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver Link | Other | Support Program |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to waitlist | Days from study enrollment to liver transplant waitlisting, assessed using OTTR. | Up to 6 months post-enrollment |
| Time to resection | Days from study enrollment to surgical resection, assessed using EMR. | Up to 6 months post-enrollment |
| Waitlisting or Resection | Proportion of participants who achieve liver transplant waitlisting or surgical resection, assessed using EMR and OTTR | Up to 6 months post-enrollment |
| Time to Death | Days from study enrollment to death, assessed using EMR and OTTR. | Up to 6 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| HCC-Related Knowledge | Score on a 10-item internally developed HCC knowledge multiple-choice test. | Baseline and 6 months post-enrollment. |
| Medical Mistrust | Score on 7-item Medical Mistrust Index. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility | Consent rate, reasons for decline, and percentage of visit completion (enrollment, support, social work), assessed in REDCap. | Ongoing through 6 months post-enrollment. |
| Usability | Score on the Modified System Usability Scale assessing intervention binder. |
Inclusion Criteria
• 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
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:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Savannah Yarnelle | Contact | (317) 278-6424 | samussel@iu.edu | |
| Regina Weber | Contact | (317) 278-3584 | reginaw@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
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20 patients will then be randomized to SOC and 20 to the Liver-Link Intervention. Randomization will be stratified by race and SES.
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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.
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| Baseline and 6 months post-enrollment. |
| Social Needs and AUD Linkage | Percentage of participants offered services for a social need, achieving improvement in a social need, and without alcohol use in the past 90 days; assessed by patient and social worker reports in REDCap. | Up to 6 months post-enrollment. |
| Quality of Life (QOL) | Composite and domain-specific scores (anxiety, depression, social role participation) on PROMIS-29 QOL Tool. | Baseline and 6 months post-enrollment. |
| 6 months post-enrollment. |
| Study Satisfaction | Score on the Client Satisfaction Questionnaire (CSQ-8; range 25-100). | 6 months post-enrollment. |
| Fidelity | Percentage of scripted social support group content delivered across sites, assessed via transcript comparison. | 6 months post-enrollment |
| Intervention Feedback - Patients | Open-ended survey of patient satisfaction with support group content, binder content, and social work. | 6 months post-enrollment. |
| Intervention Feedback - Providers | Open-ended survey assessing provider satisfaction with patient study participation and implementation of recommendations regarding social needs. | 6 months post-enrollment. |
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21218 | United States |
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