Cancer
Conditions
Keywords
patient navigation, patient-reported outcomes, supportive care in cancer, cancer survivorship
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.
Interventions
OTHERPatient-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.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency department visits, hospitalizations, and urgent care visits | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | 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. |
| Symptom severity | 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. |
| Health literacy | 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. |
Countries
United States
Contacts
CONTACTFan-Ying Chan, MS
CONTACTMatthew Heshmatipour, MPH
PRINCIPAL_INVESTIGATORAlexandre Chan, PharmD, PhD, MPH
University of California, Irvine
Outcome results
None listed