Download - Bringing the Patient Voice into Cancer Care and Research Ethan Basch, MD, MSc November 19, 2015
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Bringing the Patient Voice into Cancer Care and Research
Ethan Basch, MD, MScNovember 19, 2015
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Symptoms
• Common and often debilitating in cancer
• Recognizing symptoms is a key role of doctors and nurses– During cancer treatment– In clinical trials
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Symptoms Often Go Undetected• Up to half of
patients’ symptoms are missed during cancer treatment
Nausea
Fatigue
Months
Anorexia
Vomiting
Months
Patient-reported
Clinician-reported
3
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Serious Implications
• Under-management of symptoms during cancer treatment
• Under-documentation of symptoms and side effects in clinical trials
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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.
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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
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Examples
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Pain• Common in cancer, not well controlled
– Reported by 2/3 patients with advanced disease• Inadequate analgesics among 1/3
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Particularly True in Prostate Cancer
More than half with advanced disease report clinically meaningful pain (>4 on 0-10 NRS)
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1996
• Approved based on an old patient pain questionnaire
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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
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FDA introduced a “PRO Guidance”
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
Why So Rare?
U.S. Food & Drug
Administration
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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
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Work with Industry
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Work with Consensus Groups
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Work with National Clinical Practice Guidelines
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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”
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Developed/Tested Questionnaire and Software
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Clinician Reporting Patient Reporting
Shows Better Symptom Detection in Trials
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Improves Outcomes during Treatment
• Improved QOL, longer chemotherapy, fewer ER visits
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Recent Publications on PRO-CTCAE
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Support PRO Software for Many Trials
• UNC Cancer Center “PRO-Core"
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Patient-Centered Approaches to Quality of Care
Standards for Patient-Reported Outcome-based Performance Measures
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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
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Thank You