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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Fan-Ying Chan, MS
- Telefonnummer: 949-738-7135
- E-post: fanyinc@uci.edu
Studera Kontakt Backup
- Namn: Matthew Heshmatipour, MPH
- Telefonnummer: 9494624610
- E-post: mheshmat@hs.uci.edu
Studieorter
-
-
California
-
Irvine, California, Förenta staterna, 92617
- Chao Family Comprehensive Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Vanlig skötsel
|
|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Emergency department visits, hospitalizations, and urgent care visits
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Health-related quality of life
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
C-Reactive Protein (CRP) Level
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Alexandre Chan, PharmD, PhD, MPH, University of California, Irvine
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Undersökningstekniker
- Epidemiologiska metoder
- Datainsamling
- Hälsovårdsutvärderingsmekanismer
- Hälsovårdskvalitet
- Folkhälsa
- Miljö och folkhälsa
- Hälsovårdsekonomi och organisationer
- Resultatbedömning, hälsovård
- Resultat och processbedömning, hälsovård
- Undersökningar och frågeformulär
- Hälsoplan
- Hälsovårdsundersökningar
- Sjukvårdstjänster
- Patientutfallsbedömning
- Patienten rapporterade resultatmått
Andra studie-ID-nummer
- 5677
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