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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kali Zhou
- 電話番号：323-452-2293
- メール：kali.zhou@med.usc.edu
研究場所
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California
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Los Angeles、California、アメリカ、90033
- USC Norris Comprehensive Cancer Center
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コンタクト：
- Christopher Wong Research Coordinator
- 電話番号：323-452-2293
- メール：christophe.wong@med.usc.edu
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Los Angeles、California、アメリカ、90033
- Keck Hospital of USC
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コンタクト：
- Christopher Wong Research Coordinator
- 電話番号：323-452-2293
- メール：christophe.wong@med.usc.edu
-
Los Angeles、California、アメリカ、90033
- LA General Medical Center
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コンタクト：
- Christopher Wong Research Coordinator
- 電話番号：323-452-2293
- メール：christophe.wong@med.usc.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of participants with treatment uptake within 90 days
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion receiving treatment
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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