QoL, Symptom Research, PRO in Cancer Clinical Trials - EORTC

1. QoL, Symptom Research, PRO in Cancer Clinical Trials - EORTC Patients and Regulatory Views Why HRQoL is important to Patients? A Patients’ Perspective. Louis Denis Secretary EuropaUomo – Chair PAC ECCO November 26, Brussels

2. A patient with an opinion on cancer care is a person with a special individual expertise lacking in health managers and providers. Mrs. Els Borst 2009

3. Respect for the Patient Examinations and consultations are not to be interrupted by colleagues, telephone and other calls. Information and education is only given to the patient after the physical examination (or before). Patients’ decision for CAM treatment should be handled within the professional realm. NFK Quality Criteria Oncology Care 2009

4. Stakeholders Social Health Care Health Authority Industry Pharma Technology Insurance Public Private Professionals Practice Research Hospitals Universities General Cancer Leagues Consumers Patients Europa Uomo 2009

5. Perspectives of a Cancer Patient • Diagnosis and treatment: The lost patient. • After primary treatment: Remission, surveillance, psycho-social balance, facing outcome short & long term. • Long term: chronic disease, reintegration in society, dealing with cure, control or death. Europa Uomo 2009

6. The ‘lost’ Patient Tsunami information (professionals, media, friends) Outcomes Statistics PANIC The medical labyrinth Evidence Based, Guidelines, Nomograms Loss of personality Europa Uomo 2009

7. Patients’ Perspectives on Congress Definitions Quality of Life: WHO QoL 1993 Quality of Life is not a statistical equation but a subjective feeling of well-being. Europa Uomo 2009

8. Patients’ Perspectives on Congress Definitions Symptom Research: The gap between listed symptoms and personal bother is often ignored by the physician (weakness of surveys). Europa Uomo 2009

9. Patients’ Perspectives on Congress Definitions Patient reported outcomes in CT: An essential but neglected part of end results of treatment. HRQoL vulnerable in each step of the diagnosis and treatment. Sequential information (truth) and trusted communication helps. Europa Uomo 2009

10. HRQoL in Practice • Subjective and a patients’ perception. • Conceptual: Domain of definitions. • Operational: Related to outcome and expectations (evidence vs. consience based). • Communication and shared care (specialist, GP, nurse, relatives, groups, patients). Europa Uomo 2009

11. Cancer Management: A Patients’ Perspective • Optimal Medical Treatment Provided by professionals in a multiprofessional frame. Aim: Excellence, Updated, Balance in side- effects. • Patient Centered Care Involve patients in shared care and broad support. Aim: Holistic, QoL, Equality Europa Uomo 2009

12. HRQoL: Quo Vadis? • A fashionable, politically correct concept. • Cancer management and well-being are different but parallel rails in a train track. • Needs more long term expertise, teamwork and funding. • Needs basic integration in the health car system. Europa Uomo 2009

13. Europa Uomo quotes • To find ways and means to promote quality of life for prostate cancer patients and their families (manifesto 2004) • Choosing quality of life (QoL) above life is a patient’s right (2005) 3. Give our life back (2008) Europa Uomo 2009

14. QoL issues in Prostate Diseases Prostatitis: Needs more care than treatment BPH: QoL question mostly decisive in IPSS score Cancer: No reliable data on treatment outcomes Europa Uomo 2009

15. Side-effects of Pca ‘classic’ treatment vs. Control aged cohort Erectile Dysfunction 67% vs 18% Incontinence urine 33% vs. 4% bowel 9% vs. 2% adapt to the situation. F. Mols 2007

16. Europa Uomo’s Expectations on HRQoL in Prostate Cancer • Design treatment schedules focused on the patient (age, co-morbidity) and then the cancer. • QoL measurement and validated instruments in one single basic form to be extended to shifting problems and environment. • Improve info & communication to the unique need of the individual patient. • Adapt the curriculum of physicians and nursing to the social needs of society. • Involve patients in info education and clinical trials (ethics, consent, end review phase II, III and IV) going for long term evaluations. Europa Uomo 2009

17. Hope and Gratitude: A simple Call Out (18.09.09, Antwerp) • Governments to recognise the morbidity and mortality burdens of prostate cancer. • Governments to commit to sustainable support for basic and clinical research for new biomarkers and for clinical trials comparing different treatments. • Health professionals to educate their patients about the risk factors for prostate cancer, such as family history, ensuring those at risk are given appropriate information. • Physicians to tailor treatment to the individual patient through appropriate use of PSA testing to avoid over- or under-treatment • Society to build partnerships which help reduce the burden of disease, to identify common actions and overcome the existing inequalities around access to treatment. Europa Uomo 2009

18. Hope and Gratitude: A response of support • European Association of Urology • European School of Oncology • European Oncology Nursing Society • European Society for Medical Oncology • European Society for Surgical Oncology • European Cancer Prevention Organisation • European Society of Oncology Pharmacy • European Randomised Study of Screening for Prostate Cancer • European Cancer Patient Coalition Europa Uomo 2009

19. General Priorities to improve HRQoL Knowledge Reality Prevention Treatment Rich Poor Collaboration Olympic stand Transparant Pandora’s box Europa Uomo 2009

20. Life Expectancy • Age • Health • Activity • Address • Social Status EUomo, 2009