Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients
2026年8月26日 更新者：Alexandre Chan、University of California, Irvine
A Randomized Controlled, Type 1 Hybrid Effectiveness-implementation Trial Study to Compare the Effectiveness of a Patient-Reported Outcomes (PRO)-Driven Culturally Grounded Supportive Care Navigation in Reducing Healthcare Disparities Among Hispanic/Latinx Patients Receiving Anticancer Therapies
This is a randomized controlled, type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness of a patient-reported outcomes (PRO)-driven culturally grounded supportive care navigation in reducing healthcare disparities among Hispanic/Latinx patients receiving anticancer therapies.
The objectives of this study are: (1) to compare the effectiveness of an ePRO-driven culturally grounded supportive care navigation versus usual care (control) in Hispanic/Latinx patients undergoing anticancer treatment; and (2) to elicit perspectives from Hispanic/Latinx patients, healthcare providers, and community partners on how an ePRO-driven culturally grounded supportive care navigation can address health disparities.
調査の概要
研究の種類
介入
入学 (推定)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Fan-Ying Chan, MS
- 電話番号：949-738-7135
- メール：fanyinc@uci.edu
研究連絡先のバックアップ
- 名前：Matthew Heshmatipour, MPH
- 電話番号：9494624610
- メール：mheshmat@hs.uci.edu
研究場所
-
-
California
-
Irvine、California、アメリカ、92617
- Chao Family Comprehensive Cancer Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- At least 18 years old
- Hispanic/LatinX origin
- Newly diagnosed cancer patients
- Receiving anticancer treatment (may include combinations of intravenous or oral chemotherapy, targeted therapies, and/or immunotherapies)
Exclusion Criteria:
- Being physically and/or mentally incapable of providing written consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：普段のお手入れ
|
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実験的：Patient-Reported Outcomes (PRO)-driven supportive care navigation
|
Patients within the intervention arm will receive ePRO-driven supportive care navigation consisting of: (1) routine distress screening and care needs assessment; (2) machine learning-based acute care utilization risk prediction; (3) culturally grounded supportive care navigation; and (4) community follow-up.
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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 |
|---|---|---|
|
Emergency department visits, hospitalizations, and urgent care visits
時間枠：baseline and 3 months post-baseline
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Detailed information regarding emergency department visits, hospitalization, and urgent care visits from the first 3 months of anticancer treatment (after joining the study) will be obtained using electronic medical records, and the UCI Health Data Warehouse.
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baseline and 3 months post-baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Symptom severity
時間枠：baseline and 3 months post-baseline
|
Symptom severity will be assessed by the Edmonton Symptom Assessment System (ESAS), an 11-point Likert scale (0-10) that measures symptom intensity.
A change of at least one point is considered clinically meaningful, with higher scores indicating greater symptom burden.
|
baseline and 3 months post-baseline
|
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Health-related quality of life
時間枠：baseline and 3 months post-baseline
|
Quality of life will be measured Patient-Reported Outcomes Measurement Information System Global Health (PROMIS Global Health), a 10-item Likert scale (questions 1-8 and 10 on a 5-point scale and question 9 on an 11-point scale) instrument yielding two scores, physical health and mental health, where higher scores indicate better health.
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baseline and 3 months post-baseline
|
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Health literacy
時間枠：baseline and 3 months post-baseline
|
Health literacy will be assessed using the Brief Health Literacy Screening (BHLS) tool, with each item rated on a 5-point scale from 1 to 5, yielding a total score ranging from 3 to 15.
Higher scores indicate better health literacy.
|
baseline and 3 months post-baseline
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
C-Reactive Protein (CRP) Level
時間枠：baseline and 3 months post-baseline
|
Dried blood spot (DBS) sampling will be used to collect and analyze CRP level (mg/L)
|
baseline and 3 months post-baseline
|
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Interleukin-1 Receptor Antagonist (IL-1RA) Level
時間枠：Baseline and 3 months post-baseline
|
Dried blood spot (DBS) sampling will be used to collect and analyze IL-1RA level (pg/mL)
|
Baseline and 3 months post-baseline
|
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Interleukin-6 (IL-6) Level
時間枠：Baseline and 3 months post-baseline
|
Dried blood spot (DBS) sampling will be used to collect and analyze IL-6 level (pg/mL)
|
Baseline and 3 months post-baseline
|
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Tumor Necrosis Factor-alpha (TNF-α) Level
時間枠：Baseline and 3 months post-baseline
|
Dried blood spot (DBS) sampling will be used to collect and analyze TNF-α level (pg/mL)
|
Baseline and 3 months post-baseline
|
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TNF Receptor Type II (TNF-RII) Level
時間枠：Baseline and 3 months post-baseline
|
Dried blood spot (DBS) sampling will be used to collect and analyze TNF-RII level (pg/mL)
|
Baseline and 3 months post-baseline
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Alexandre Chan, PharmD, PhD, MPH、University of California, Irvine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年8月22日
QC基準を満たした最初の提出物
2026年8月22日
最初の投稿 (実際)
2026年8月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月31日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-43
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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