Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Fan-Ying Chan, MS
- 电话号码：949-738-7135
- 邮箱：fanyinc@uci.edu
研究联系人备份
- 姓名：Matthew Heshmatipour, MPH
- 电话号码：9494624610
- 邮箱：mheshmat@hs.uci.edu
学习地点
-
-
California
-
Irvine、California、美国、92617
- Chao Family Comprehensive Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：日常护理
|
|
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Emergency department visits, hospitalizations, and urgent care visits
大体时间：baseline and 3 months post-baseline
|
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. |
baseline and 3 months post-baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Health-related quality of life
大体时间：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. |
baseline and 3 months post-baseline
|
|
Symptom severity
大体时间：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
|
|
Health literacy
大体时间：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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
C-Reactive Protein (CRP) Level
大体时间：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
|
|
Interleukin-1 Receptor Antagonist (IL-1RA) Level
大体时间：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
|
|
Interleukin-6 (IL-6) Level
大体时间：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
|
|
Tumor Necrosis Factor-alpha (TNF-α) Level
大体时间：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
|
|
TNF Receptor Type II (TNF-RII) Level
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：Alexandre Chan, PharmD, PhD, MPH、University of California, Irvine
出版物和有用的链接
一般刊物
- Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24. doi: 10.1200/JCO.2004.06.078.
- Kotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S, MacGillivray S. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014 May 10;32(14):1480-501. doi: 10.1200/JCO.2013.53.5948. Epub 2014 Apr 7.
- Alvidrez J, Castille D, Laude-Sharp M, Rosario A, Tabor D. The National Institute on Minority Health and Health Disparities Research Framework. Am J Public Health. 2019 Jan;109(S1):S16-S20. doi: 10.2105/AJPH.2018.304883.
- Cooper LA, Roter DL, Johnson RL, Ford DE, Steinwachs DM, Powe NR. Patient-centered communication, ratings of care, and concordance of patient and physician race. Ann Intern Med. 2003 Dec 2;139(11):907-15. doi: 10.7326/0003-4819-139-11-200312020-00009.
- Wagner LI, Schink J, Bass M, Patel S, Diaz MV, Rothrock N, Pearman T, Gershon R, Penedo FJ, Rosen S, Cella D. Bringing PROMIS to practice: brief and precise symptom screening in ambulatory cancer care. Cancer. 2015 Mar 15;121(6):927-34. doi: 10.1002/cncr.29104. Epub 2014 Nov 6.
- Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014 Sep 29;106(9):dju244. doi: 10.1093/jnci/dju244. Print 2014 Sep.
- Basch E, Barbera L, Kerrigan CL, Velikova G. Implementation of Patient-Reported Outcomes in Routine Medical Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:122-134. doi: 10.1200/EDBK_200383.
- Cheung YT, Chan A, Charalambous A, Darling HS, Eng L, Grech L, van den Hurk CJG, Kirk D, Mitchell SA, Poprawski D, Rammant E, Ramsey I, Fitch MI, Chan RJ. The use of patient-reported outcomes in routine cancer care: preliminary insights from a multinational scoping survey of oncology practitioners. Support Care Cancer. 2022 Feb;30(2):1427-1439. doi: 10.1007/s00520-021-06545-7. Epub 2021 Sep 15.
- Chan RJ, Milch VE, Crawford-Williams F, Agbejule OA, Joseph R, Johal J, Dick N, Wallen MP, Ratcliffe J, Agarwal A, Nekhlyudov L, Tieu M, Al-Momani M, Turnbull S, Sathiaraj R, Keefe D, Hart NH. Patient navigation across the cancer care continuum: An overview of systematic reviews and emerging literature. CA Cancer J Clin. 2023 Nov-Dec;73(6):565-589. doi: 10.3322/caac.21788. Epub 2023 Jun 26.
- Santos Salas A, Fuentes Contreras J, Armijo-Olivo S, Saltaji H, Watanabe S, Chambers T, Walter L, Cummings GG. Non-pharmacological cancer pain interventions in populations with social disparities: a systematic review and meta-analysis. Support Care Cancer. 2016 Feb;24(2):985-1000. doi: 10.1007/s00520-015-2998-9. Epub 2015 Nov 10.
- Duma N, Velazquez AI, Franco I, Kiel L, Levit LA, Schenkel C, Kirkwood K, Green S, Rodriguez G. Donde Estan? Latinx/Hispanic Representation in the Oncology Workforce: Present and Future. JCO Oncol Pract. 2022 May;18(5):388-395. doi: 10.1200/OP.22.00153.
- Seible DM, Kundu S, Azuara A, Cherry DR, Arias S, Nalawade VV, Cruz J, Arreola R, Martinez ME, Nodora JN, Rahn DA, Murphy JD. The Influence of Patient-Provider Language Concordance in Cancer Care: Results of the Hispanic Outcomes by Language Approach (HOLA) Randomized Trial. Int J Radiat Oncol Biol Phys. 2021 Nov 15;111(4):856-864. doi: 10.1016/j.ijrobp.2021.05.122. Epub 2021 May 29.
- Martinez KA, Snyder CF, Malin JL, Dy SM. Is race/ethnicity related to the presence or severity of pain in colorectal and lung cancer? J Pain Symptom Manage. 2014 Dec;48(6):1050-9. doi: 10.1016/j.jpainsymman.2014.02.005. Epub 2014 Apr 18.
- Reyes-Gibby CC, Anderson KO, Shete S, Bruera E, Yennurajalingam S. Early referral to supportive care specialists for symptom burden in lung cancer patients: a comparison of non-Hispanic whites, Hispanics, and non-Hispanic blacks. Cancer. 2012 Feb 1;118(3):856-63. doi: 10.1002/cncr.26312. Epub 2011 Jul 12.
- Duran DG, Perez-Stable EJ. Novel Approaches to Advance Minority Health and Health Disparities Research. Am J Public Health. 2019 Jan;109(S1):S8-S10. doi: 10.2105/AJPH.2018.304931. No abstract available.
- John DA, Kawachi I, Lathan CS, Ayanian JZ. Disparities in perceived unmet need for supportive services among patients with lung cancer in the Cancer Care Outcomes Research and Surveillance Consortium. Cancer. 2014 Oct 15;120(20):3178-91. doi: 10.1002/cncr.28801. Epub 2014 Jul 1.
- Chan A, Ng DQ, Arcos D, Heshmatipour M, Lee BJ, Chen A, Duong L, Van L, Nguyen T, Green V, Hoang D. Electronic Patient-Reported Outcome-Driven Symptom Management by Oncology Pharmacists in a Majority-Minority Population: An Implementation Study. JCO Oncol Pract. 2024 Dec;20(12):1744-1754. doi: 10.1200/OP.24.00050. Epub 2024 Jul 15.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 5677
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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