Quality of Life Research within NCCTG

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It is worthwhile to secure the happiness of the patient as well as to prolong his life.Dr. William J. Mayo, 1935. Mayo Clinic has a long track record in considering patient quality of life!. Why is QOL important? Evidence from the Literature. Fatigue related to patient survival (Chochinov, 199

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Quality of Life Research within NCCTG

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1. Quality of Life Research within NCCTG 4th Annual NCCTG Patient Advocate Symposium August 9, 2006

3. Why is QOL important? Evidence from the Literature Fatigue related to patient survival (Chochinov, 1998, JPC) Social support and symptom distress prognostic for survival (Silliman, 1998, Cancer; Degner, 1995, JPSM) Group counseling improves patient survival (Spiegel, 1989, Lancet) Among patients with advanced cancer, those with higher QOL live longer (Sloan, 1998, JCO) Patients with good appetite and who say they are doing well live longer (Sloan, 2002, JCO)

4. 3 Operational Guidelines Facilitate the implementation of QOL in NCCTG treatment trials as appropriate. Develop new methodology to increase the precision and efficiency of QOL assessment. Explore the relationship between genetics and QOL. Improve the clinical trial patient experience to inform and improve oncology treatment clinical trial design and conduct. Continue methodological work on estimating the clinical significance and the value-added of QOL assessments in oncology treatment trials. Initiate protocols directed at QOL endpoints to complement the treatment trial research portfolio.

5. Facilitating Implementation of QOL in NCCTG Treatment Trials QOL endpoints in 28 (46%) of the 61 NCCTG treatment trials opened (2001-2005) QOL assessments were done on 4,401 patients from 2001-2005 Over 50 different assessments involved Baseline completion rate over 90% Post-baseline completion over 80%

8. A Unified Theory for the Clinical Significance of QOL Scores We have demonstrated that the various mathematical and clinical methods for assessing QOL can be equated and combined into a single guideline Sloan: Cancer Integrative Medicine, 2003 Dueck: Drug Information Journal (submitted), 2006 Sloan: J Chronic Obs Pul Dis, 2005 Norman: Exp Rev Pharmaco Outcomes Res, 2004 A change of a 1/2 standard deviation (10 points on a 0 to 100 scale) is a minimally required shift for clinical significance on any domain or individual item of QOL

10. The Six Papers: Clinsig II Sloan et al. Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clinic Proc 77(4):367-70, 2002. Guyatt et al. Methods to explain the clinical significance of health status measures. Mayo Clinic Proc 77(4):371-83, 2002. Cella et al. Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clinic Proc 77(4):384-92, 2002. Sloan et al. Assessing the clinical significance of single items relative to summated scores. Mayo Clinic Proc 77(5):479-87, 2002. Frost et al. Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clinic Proc 77(5):488-94, 2002. Sprangers et al. Assessing meaningful change in quality of life over time: a users' guide for clinicians. Mayo Clinic Proc 77(6):561-71, 2002. Symonds et al. The clinical significance of quality-of-life results: practical considerations for specific audiences. Mayo Clinic Proc 77(6):572-83, 2002.

12. Do we need this?

13. Or is this sufficient?

14. Or even this?

15. Individual Patient QOL Data Over Time

17. QOL Minimization Initiatives Less is more Single-item LASAs for 12 common endpoints Protocol-specific single items Professional data collection booklets Forms bank / bibliography of virtually any tool you would ever need BOTTOM LINE: QOL assessment can be incorporated easily & efficiently

18. Combining QOL and Survival “A day above ground is a good day.” Classify days above ground by the health states. Oncology health states are TOX, REL, TWiST.

21. QOL & Genetics

23. New Protocols Real time feedback of QOL data to physicians/patients (Michele Halyard) N0591: A Pooled Analysis to Assess the Value Added of Patient-Reported Outcomes (PROs) in Cooperative Group Oncology Clinical Trials N0691: A Meta Analysis of QOL Differences by Race in Patients on NCCTG and Mayo Trials N0392: “Was it worth it” Protocol

24. N0392: “Was it worth it” Protocol

26. QOL Monograph (Part 1 and 2) Current Problems in Cancer Part 1: Nov/Dec 2005 Part 2: Nov/Dec 2006 Optimal timing for QOL assessments Combining information across symptom studies Presenting longitudinal data Incorporating clinical significance into a study Handling missing data Quality of life from the patient’s perspective: can we believe the patient? Impact of quality of life measurements on the patient Future directions in QOL research How does QOL differ from response and survival? Does QOL provide the same information as toxicity data? Genetics and QOL Is the use of QOL data really any different than other medical testing? Choosing the ‘correct' assessment tool Analyzing the ‘correct' endpoint Dealing with multiple endpoints Combining symptom and survival data Integrating QOL assessments for clinical and research purposes

28. PROACT Meeting

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