Office of Patient-Centered Outcomes Research

Using patient-focused approaches to enhance our understanding of the patient experience

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The goal of the Office of Patient-Centered Outcomes Research (OPCORe) is to integrate the voice of the patient, and in particular, the use of patient-centered outcomes into early-phase clinical trials.

About Our Office

Learn about our vision and mission, resources and publications.

Vision and Mission

Resources

Publications

What are clinical outcomes assessments?

Patient-centered outcomes assessment starts with an understanding of the impact of a disease and its treatment on patients, and what patients value from a treatment perspective. It measures things that are important to patients, such as how a treatment will affect symptoms and their day-to-day functioning.

Such patient-focused approaches use clinical outcomes assessments (COAs), in which information is gathered on the impact of treatment on the person and can markedly enhance the understanding of the patient experience in cancer clinical trials.

COAs can broadly be classified into four distinct groups based on how data is collected:

PROs – patient-reported outcomes
ClinROs - information gleaned from clinical observation
ObsROS - other observer reported outcomes (ObsROs),
PerfOs - and data from performance on a task or test (PerfOs)

In cancer-related clinical trials, regulatory agencies and advocacy groups increasingly encourage using PROs to describe the clinical benefit of a therapeutic regimen.

This includes using information on disease-associated symptoms or functions to help determine treatment efficacy and understand treatment-associated side effects. These measures, which collect information directly from the patient, without interpretation by somebody else, improve researchers’ understanding of the patient perspective on the treatment’s impact.

Why are patient-centered outcomes important?

Regulators, clinicians and patients need meaningful information about a treatment’s benefits and risks in order to make important treatment decisions.

Additionally, these measures also provide valuable insights about the impact of the disease and its treatment that help improve patient care even when the treatment does not turn out to have sufficient activity against the cancer.

Why are patient-centered outcomes important in early-phase trials?

There has been a shift in the clinical trial landscape towards early-phase studies, where data from well-designed and pivotal phase I/II trials increasingly leads to accelerated drug approval.

Early-phase clinical trials primarily investigate toxicity and tolerability. Standard toxicity assessments provide only limited or inadequate information. Patient-focused approaches using COAs to gather information about the impact of treatment on the person, not only the tumor, would markedly enhance the understanding of the patient experience in these trials.

Standardizing and incorporating PROs into earlier phase trials would allow them to be optimized, improve study design and allow more rigorous and systematic assessment of PROs in later-phase trials.

These more systematic PRO designs may then increase the chance of a PRO being incorporated into a product’s label. That could ultimately empower patients, caregivers, and healthcare providers to make more informed treatment decisions leading to better outcomes and better quality of life for patients.

For Researchers

We look forward to collaborating with researchers at different institutions.

Information for Researchers

CCR Researchers

Ongoing Studies

For Patients and Advocates

Learn about how we are adding the voice of the patient into early-phase cancer clinical trials.

What Are Patient-Centered Outcomes?

Frequently Asked Questions

For Trainees and Trainers

Our postbac fellows receive strong mentoring as they work with our multidisciplinary research teams. Learn more about opportunities to incorporate PROs into clinical research training.

Postbac Training at OPCORe

General Training Information

News & Events

New Manuscript Published

03/09/23 - In this phase I trial of combining ado-trastuzumab emtansine (T-DMI) with metronomic temolozomide (TMZ) in women with metastatic HER2+ breast cancer to the brain after previous occurrence and local treatment, patients who responded to treatment showed lower symptom burden, less interference with daily functions and better cognitive function. These outcomes were measured using the brain tumor module of the MD Anderson Symptom Inventory and the NeuroQOL Cognition Function with completion rates of 99% by Cycle 15 and 90% by Cycle 41. Read more

Welcome Our New Trainees!

02/06/2023 - OPCORe welcomes the newest members to our team. Ciara Locke and Sefanit Berhanu, newest members of OPCORe, participated in the day of action activity and made hygiene kits for the Small Things Matter charity organization.

Small Things Matter — Ciara Locke (left) and Sefanit Berhanu (right)

The link between psychological distress and survival in solid tumor patients: A systematic review

01/11/23 - Past research has shown that solid tumor patients experience high levels of psychological distress at the time of diagnosis, yet little is known about how this symptom may adversely impact clinical outcomes. This systematic review explored the literature linking distress with survival in solid tumor patients and found a weak to moderate relationship, suggesting that this symptom may be a negative prognostic factor. The authors hope this work will provide better understanding of the clinical implications of untreated distress and that it may enable development of targeted interventions for cancer patients. Learn more

Relationship between RANO-PRO Working Group standardized priority constructs and disease progression among malignant glioma patients: A retrospective cohort study

11/14/22 - Recognizing the importance of clinical outcomes assessments (COAs), the Response Assessment in Neuro-Oncology-Patient Reported Outcome (RANO-PRO) Working Group recommended inclusion of core symptoms and functions in clinical care or research for malignant glioma patients. This study evaluated the association of the recommended symptoms (pain, perceived cognition, seizures, aphasia, symptomatic adverse events) and functions (weakness, walking, work, usual activities) with disease progression in these patients. Learn more

Dr. Mendoza speaks at the International Society for Quality of Life Research

10/20/22 - Dr. Mendoza discussed the use of patient-reported outcomes in predicting severe adverse events in cancer patients receiving immunotherapy during the 29^thannual conference of the International Society for Quality of Life Research held in Prague, Czech Republic Oct 19-22.

Dr. Mendoza presents at the International Society for Quality of Life Research

Patient-reported symptom burden in patients with rare cancers receiving pembrolizumab in a phase II Clinical Trial

10/15/22 - In a prior study, it has been shown that pembrolizumab, an immune checkpoint inhibitor has favorable toxicity profile and antitumor activity in advanced rare cancer patients (e.g., squamous cell carcinoma of the skin, carcinoma of unknown primary, paraganglioma). In this companion study to that early phase trial evaluating pembrolizumab, we focused on how patients feel and function while undergoing treatment. We hope that this information will assist clinicians with their symptom management approach, aid researchers in designing symptom intervention trials and help patients with what to expect during their treatment. Learn more