- Incorporating patient-reported outcomes (PROs) into trial design and clinical assessment can improve QoL and outcomes in patients with breast cancer and other malignancies while providing critical information in the assessment of cancer therapies.
- The FDA defines a PRO as "any report of the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by a clinician or anyone else."
- Research shows that patients tend to report higher levels of symptoms, sooner, than clinicians.
- Several studies (found here, here, and here) show high patient response rates in computer-reported symptoms, starting at about 80%+ and remaining at 60%+ into the second and third years of treatment.
- Tracking PROs has resulted in higher rates of improved QoL and reduced emergency department visits and OS, as shown here and here.
- Choice of PROs depends on population, timing, cost, and measure specificity and sensitivity (toxicities, adverse events, specific symptoms, functional status, QoL).
- The National Cancer Institute website has a PRO version of the Common Terminology Criteria for Adverse Events tool for creating custom forms to collect adverse events data in clinical trials.
- An additional option is Patient Reported Outcomes Measurement Information System (PROMIS).
- Emerging research is exploring the use of biometric data (sleep, time at home, travel, activity levels) in assessing QoL
- Funding: Presenter disclosed no disclosures or external funding.