A Randomized Controlled Trial to Compare the Effectiveness of a Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients

NCT07787806 | Not Yet Recruiting DMC

• 1 other identifier: 25-43
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

patient navigation; patient-reported outcomes; supportive care in cancer; cancer survivorship

Outcome Measures

Primary Outcomes (1)

• ED visits, hospitalizations, and urgent care visits

  Detailed information regarding ED visits, hospitalization, and urgent care visits from the first 3 months of anticancer treatment (after joining the study) will be obtained using EMR, and the UCI Health Data Warehouse.

  baseline and 3 months post-baseline

Secondary Outcomes (3)

• Health-related quality of life

  baseline and 3 months post-baseline

• Symptom severity

  baseline and 3 months post-baseline

• Health literacy

  baseline and 3 months post-baseline

Other Outcomes (1)

• Inflammatory biomarkers

  baseline and 3 months post-baseline

Study Arms (2)

Usual care

NO INTERVENTION

Patient-Reported Outcomes (PRO)-driven supportive care navigation

EXPERIMENTAL

Other: Patient-Reported Outcomes (PRO)-driven supportive care navigation

Interventions

Patient-Reported Outcomes (PRO)-driven supportive care navigation OTHER

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.

Patient-Reported Outcomes (PRO)-driven supportive care navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Being physically and/or mentally incapable of providing written consent

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center

Irvine, California, 92617, United States

Location

Related Publications (17)

• 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.

  PMID: 14966096 BACKGROUND

• 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.

  PMID: 24711559 BACKGROUND

• 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.

  PMID: 30231381 BACKGROUND

• 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.

  PMID: 34524527 BACKGROUND

• 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.

  PMID: 25265940 BACKGROUND

• 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.

  PMID: 25376427 BACKGROUND

• 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.

  PMID: 37358040 BACKGROUND

• 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.

  PMID: 30699025 BACKGROUND

• 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.

  PMID: 26556211 BACKGROUND

• 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.

  PMID: 35544646 BACKGROUND

• 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.

  PMID: 34058256 BACKGROUND

• 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.

  PMID: 14644893 BACKGROUND

• 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.

  PMID: 24747225 BACKGROUND

• 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.

  PMID: 21751190 BACKGROUND

• 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.

  PMID: 30699017 BACKGROUND

• 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.

  PMID: 24985538 BACKGROUND

• 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.

  PMID: 39008806 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Patient Reported Outcome Measures

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Alexandre Chan, PharmD, PhD, MPH

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan-Ying Chan, MS

CONTACT

949-738-7135; fanyinc@uci.edu

Matthew Heshmatipour, MPH

CONTACT

9494624610; mheshmat@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacy

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)