Social Determinants of Health HCC Trial
A Randomized Controlled Interventional Trial of a Social Determinants of Health and Patient Navigation Program to Improve Treatment Utilization Among Low-income Patients With Hepatocellular Carcinoma
연구 개요
상태
정황
상세 설명
Social determinants of health (SDOH) play a central role in drop-offs at each step of the cancer care cascade for patients living in poverty. Social barriers have been shown to result in delays in care, increased non-compliance, and poorer outcomes. Importantly, negative SDOH among patients with HCC may impact receipt of therapy, a critical contributor to improved survival. Studies have shown that even small delays in therapy (more than 3 months from diagnosis) can lead to worse survival. The treatment landscape for HCC is complex, ranging from surgical options to locoregional therapies to immunotherapy, and requires multidisciplinary input from hepatologists, oncologists, interventional radiologists, and surgeons and frequent touchpoints with the healthcare system to successfully complete treatment. Social barriers can make navigating these complexities especially challenging for resource-poor patients with HCC.
The investigators hypothesize that intervening upon key social determinants of health along with patient navigation will lead to improvements in adherence to care and timely receipt of guideline-concordant treatment among underserved patients with HCC. Specifically, the study targets three modifiable and inter-related social barriers - unreliable transportation, housing instability, and food insecurity - that have previously been shown to be prevalent among patients with cirrhosis.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kali Zhou
- 전화번호: 323-452-2293
- 이메일: kali.zhou@med.usc.edu
연구 장소
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California
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Los Angeles, California, 미국, 90033
- USC Norris Comprehensive Cancer Center
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연락하다:
- Christopher Wong Research Coordinator
- 전화번호: 323-452-2293
- 이메일: christophe.wong@med.usc.edu
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Los Angeles, California, 미국, 90033
- Keck Hospital of USC
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연락하다:
- Christopher Wong Research Coordinator
- 전화번호: 323-452-2293
- 이메일: christophe.wong@med.usc.edu
-
Los Angeles, California, 미국, 90033
- LA General Medical Center
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연락하다:
- Christopher Wong Research Coordinator
- 전화번호: 323-452-2293
- 이메일: christophe.wong@med.usc.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults (18 years or older)
- Diagnosis of HCC (BCLC Stage A-C)
- Uninsured or underinsured (i.e., Medicaid as primary or secondary insurance)
- Able to provide informed consent
Exclusion Criteria:
- Non-HCC liver tumors
- BCLC Stage D and/or Child Pugh C cirrhosis (latter unable to receive treatment due to poor liver function)
- No plans for cancer treatment for any reason including patient refusal (best supportive care only)
- Only oral systemic therapy planned (i.e., tyrosine kinase inhibitors)
- Incarcerated patients or pregnant patients
- Unable to provide informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SDOH and patient navigation program
Transportation support through Lyft rideshares, housing support through Hyatt House LA - University Medical Center, and meal support through Project Angel Food LA
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Social resources to be offered under our SDOH program will include 1) rideshares to treatment-related visits, 2) hotel stays for treatment-related visits, and/or 3) a 12-week meal delivery program.
Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.
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활성 비교기: Patient navigation only
For the duration of the intervention, patients will have access to patient navigation as per usual care.
The intensity and frequency of navigation is dependent on the treating clinic; the provider of navigation (whether nurse vs social worker) is also variable by clinic.
This includes: coordination of care including assistance with scheduling follow-up visits, labs, imaging, and procedures, help with filling out forms for insurance, FMLA or disability benefits, facilitating communication with treating providers, referral to community and patient support groups, providing patients with educational materials and resources, check-ins on well-being and any cancer- or treatment-related concerns
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Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants with treatment uptake within 90 days
기간: 90 days
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The primary outcome is receipt of timely treatment for HCC defined as within 90 days of randomization
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90 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion receiving treatment
기간: 2 years
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The secondary endpoint will evaluate the proportion of participants receiving treatment at any timepoint after randomization until end of study
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2 years
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Number of acute care visits
기간: 2 years
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Utilization of acute care settings such as emergency room visits or hospital admissions during the study period
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2 years
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Patient-reported outcome - FACIT-COST Survey
기간: 6 months
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Differences in financial toxicity as measured by the COST: A FACIT Measure of Financial Toxicity (FACIT-COST) Survey at the end of the intervention period (range 0-48; higher score means better financial well-being)
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6 months
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Patient reported outcome - FACT-HEP Survey
기간: 6 months
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Comparison of difference in health-related quality of life based on the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-HEP) Survey score (range 0-180; higher score means better quality of life)
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6 months
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Mortality
기간: 2 years
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Proportion of participants who are alive at end of study period
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2 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UP-25-00802
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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