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Bringing the Patient Voice into Cancer Care and Research Ethan Basch, MD, MSc November 19, 2015 Symptoms • Common and often debilitating in cancer • Recognizing symptoms is a key role of doctors and nurses – During cancer treatment – In clinical trials Symptoms Often Go Undetected • Up to half of patients’ symptoms are missed during cancer treatment Patientreported Fatigue Anorexia Nausea Vomiting Clinicianreported Months 3Months Serious Implications • Under-management of symptoms during cancer treatment • Under-documentation of symptoms and side effects in clinical trials Research on “Patient-Reported Outcomes” • Develop questionnaires and software to enable patient self-reporting of symptoms, physical functioning and “quality of life” • Test these approaches during routine chemotherapy care and in clinical trials nationally • Work closely with NCI, FDA, pharmaceutical industry, etc. UNC is a National Leader in this Area • Angie Smith, MD • Arlene Chung, MD • Bryce Reeve, PhD • Antonia Bennett, PhD • Bill Wood, MD • Hy Muss, MD • Grant Williams, MD Examples Pain • Common in cancer, not well controlled – Reported by 2/3 patients with advanced disease • Inadequate analgesics among 1/3 Particularly True in Prostate Cancer More than half with advanced disease report clinically meaningful pain (>4 on 0-10 NRS) 1996 • Approved based on an old patient pain questionnaire 1997-2014 • Only 1 other oncology drug approved by FDA based on patient-reported information (Ruxolitinib, 2011) • Surprising, given how common symptoms and functional impairment are in oncology Why So Rare? FDA introduced a “PRO Guidance” U.S. Food & Drug Administration Outlined standards - Patient interviews - Testing - Relevance to trials - Implementation, analysis Groundbreaking… but overly stringent, and industry was largely unwilling and unable to adhere in most cases Researcher Role • Worked with FDA on approach to PROs in oncology – – – – – – Outcome: pain intensity Measure: 0-10 NRS (BPI) Recall: 24 hours Meaningful change: 30% or 2 points Analgesic use: integrated into design Analysis approaches Work with Industry Work with Consensus Groups Work with National Clinical Practice Guidelines A Second Example • Measuring symptom side effects in clinical trials – Clinicians miss many of these – UNC researchers led development of approach for patients to report their own side effects • Developed for the National Cancer Institute • Called the “PRO-CTCAE” Developed/Tested Questionnaire and Software Shows Better Symptom Detection in Trials Clinician Reporting Patient Reporting Improves Outcomes during Treatment • Improved QOL, longer chemotherapy, fewer ER visits Recent Publications on PRO-CTCAE Support PRO Software for Many Trials • UNC Cancer Center “PRO-Core" Patient-Centered Approaches to Quality of Care Standards for PatientReported Outcome-based Performance Measures PROs in Geriatrics • Key to measure the patient experience – risk of comorbidities; functional impairments – E.g., the GA • Older patients are enthusiastic to self-report • Enables communication • Methods research considerations – What outcomes, how ask questions, how often, how use the information, how report results? – Requires interdisciplinary collaboration Thank You