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 trial explores a new method to assist Hispanic/Latinx cancer patients by using patient-reported outcomes (PROs) to guide their care. The researchers aim to determine if this approach, known as PRO-driven supportive care navigation, can enhance the support these patients receive compared to usual care. They aim to reduce healthcare disparities by tailoring support to cultural needs. This trial suits Hispanic/Latinx individuals newly diagnosed with cancer and undergoing treatments such as chemotherapy or immunotherapy. As an unphased trial, it offers a unique opportunity to contribute to research that could improve culturally tailored cancer care.

What prior data suggests that this PRO-driven supportive care navigation is safe for patients?

Research has shown that supportive care methods, such as using patient feedback to guide care, are generally safe for individuals undergoing cancer treatment. These methods aim to enhance patients' quality of life by addressing their physical and emotional needs. Although no specific side effects are linked to this type of care, similar methods have been well-tolerated.

As this study does not involve a new drug or surgery, the risk of harm remains low. Instead, it focuses on using patient feedback to ensure they receive the necessary support during treatment. Overall, the supportive care method used in this trial is expected to be safe and beneficial for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the PRO-driven supportive care navigation because it personalizes cancer care by using patient-reported outcomes to guide treatment decisions. Unlike traditional approaches that often rely heavily on clinical assessments alone, this method actively incorporates the patient's own feedback about their symptoms and quality of life. This can lead to more responsive and tailored care, potentially improving patient satisfaction and overall outcomes. By focusing on the patient's voice, this approach aims to enhance the precision and effectiveness of supportive care in cancer treatment.

What evidence suggests that this PRO-driven supportive care navigation is effective for reducing healthcare disparities among Hispanic/Latinx cancer patients?

Research has shown that asking patients about their experiences can greatly improve cancer care. This includes understanding their fatigue, pain levels, and emotional stress. In this trial, some participants will receive Patient-Reported Outcomes (PRO)-driven supportive care navigation, which studies have found can enhance quality of life and reduce stress. These programs simplify treatment understanding, leading to higher satisfaction. Additionally, incorporating patient feedback in cancer care is linked to better symptom management and longer survival. Overall, patient navigation has proven effective in reducing disparities in care and improving outcomes for cancer patients.678910

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+

Citations

Patient-reported Outcomes-driven Supportive Care ...

The objectives of this study are: (1) to compare the effectiveness of an ePRO-driven culturally grounded supportive care navigation versus usual care (control) ...

Effects of Patient Navigation on Patient Satisfaction Outcomes

The objectives of this study are to test the effects of PN on patient satisfaction with cancer care, assess patients' satisfaction with navigators, and examine ...

Patient-Reported Outcomes in Oncology Care

In oncology care they capture fatigue, pain, emotional distress and treatment side-effects, offering insights beyond clinician-rated assessments ...

The Lessening the Impact of Financial Toxicity Clinical Trial

The primary effectiveness outcome was change in FACIT-COST score, pre- versus post-LIFT implementation. Patient-level secondary outcomes ...

Effectiveness of patient navigation on outcomes across the ...

Implementation outcomes most concerned acceptability and feasibility, while intervention outcomes included improvements in knowledge, psychosocial wellbeing,

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Supportive Care in Cancer | Springer Nature Link

Supportive Care in Cancer presents the most recent scientific and clinical practice information on all aspects of supportive care in cancer patients.

SUPPORTIVE | English meaning - Cambridge Dictionary

SUPPORTIVE definition: 1. showing agreement and giving encouragement: 2. giving help and encouragement: 3. showing…. Learn more.

Supportive Services for Veteran Families - VA Homeless ...

The Supportive Services for Veteran Families (SSVF) grant helps organizations support low‐income Veteran families who are homeless or at risk