PRO-driven Supportive Care for Cancer

FC
MH
Overseen ByMatthew Heshmatipour, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AC

Alexandre Chan, PharmD, PhD, MPH

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latinx adults who are currently receiving treatment for cancer. Participants should be able to report their symptoms and experiences during care.

Inclusion Criteria

I have been recently diagnosed with cancer.
Hispanic/LatinX origin
I am currently receiving treatment for cancer.
See 1 more

Exclusion Criteria

I am unable to give written consent due to physical or mental limitations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anticancer therapies and are monitored using patient-reported outcomes (PRO) to guide supportive care navigation

12 weeks
Regular visits as per treatment protocol

Follow-up

Participants are monitored for symptom severity, quality of life, and other health indicators post-treatment

12 weeks
Follow-up assessments at baseline and 3 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study compares a new supportive care program that uses patient-reported outcomes (ePRO) and is tailored to Hispanic/Latinx culture, against usual cancer care. Patients are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Patient-Reported Outcomes (PRO)-driven supportive care navigationExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+