Advances in Quality of Life Research

1. Advances in Quality of Life Research Patient Advocate Symposium June 18, 2003

3. We can extend the quantity of life, but it is more important to improve the quality of life. Stephen Hawkings When the cure remains elusive, it is time to treat the patient, not the disease. Ian Tannock, NEJM, 1986

4. 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)

5. What is your QOL right now? Has it changed significantly since you arrived? Is it significantly different from your neighbor? How can you tell? How can you tell others?

9. Status of QOLin Health Care Research �The Plaintive cry of the medical profession whenever QOL assessment presents itself is to give us something we can understand, use ourselves, explain to the patient and can be completed in less than five minutes�. - ML Feldstein Cancer 1991

10. Programmatic Themes I. Assess QOL within trials with efficiency, consistency, specificity, when necessary II. Improve QOL methodology III. Develop intervention studies targeted at QOL endpoints Three themes guide the QOL working group. First, we will serve as a resource to ensure that QOL data collected are minimally sufficient and scientifically sound. QOL assessment will be included only in clinical trials where such data are essential to meet the study goals and improve standards of care. This theme is of primary importance because any NCCTG QOL assessment must be undertaken with the realities of the community clinical oncology practice in mind. The second theme is to carry out research which will improve the methods by which QOL data are collected. The third theme is to develop treatment intervention trials targeted at QOL endpoints that represent issues faced by patients treated in community oncology practices.Three themes guide the QOL working group. First, we will serve as a resource to ensure that QOL data collected are minimally sufficient and scientifically sound. QOL assessment will be included only in clinical trials where such data are essential to meet the study goals and improve standards of care. This theme is of primary importance because any NCCTG QOL assessment must be undertaken with the realities of the community clinical oncology practice in mind. The second theme is to carry out research which will improve the methods by which QOL data are collected. The third theme is to develop treatment intervention trials targeted at QOL endpoints that represent issues faced by patients treated in community oncology practices.

14. Why is it difficult to define �clinical significance� for QOL? Pain analogy 25 years ago physicians were the sole raters of patient pain JCAHO 2000 guideline: every patient�s pain to be assessed upon intake on a 0-10 scale Time and experience and shift from �med-centrism� alleviates novelty and skepticism

15. Why is it difficult to define �clinical significance� for QOL? Blood pressure analogy 100 years ago, clinical significance of BP scores was unknown massage therapy was the gold standard present guidelines for BP clinical significance today?

17. Do we need this?

18. Or is this sufficient?

19. Or even this?

20. 

22. Quality of Life (QOL) Minimization Initiatives Less is more single-item LASA�s for 12 common endpoints protocol-specific single items �Was it worth it� (WIWI) items Data collection booklets Forms bank / bibliography of virtually any tool you would ever need bottom line: QOL assessment can be incorporated easily, efficiently

27. A Unified Theory for QOL Scores We have demonstrated that the various mathematical and clinical methods for assessing QOL can be equated and combined into a single, simple guideline A change of 1/2 S.D. (10 points on a 100-point scale) is a minimally required shift for clinical significance on any domain or individual item of QOL Sloan et al, JDIA, 2002; Norman et al, Medical Care, 2003; Sloan et al, (in press)

28. Therapeutic Harp Treatment A randomized, controlled two-period crossover clinical trial

29. Schema

30. Percent of Patients Achieving a 1/2 SD Improvement

33. Combining QOL and Survival �A day above ground is a good day�. QOL is zero when you die, but is it always above zero when you are alive�. Classify days above ground by the health state. Oncology health states are TOX, REL, TWiST.

37. Tangible results: new protocols 2nd winter institute: Scottsdale March 28-April 7, 2003 Real time feedback of QOL data to physicians/patients (Michele Halyard) Web-based decision-making for breast cancer patients (Teri Britt) Relationship among stress, immune function, and breast cancer in patients with abnormal mammograms (Barb Pockaj) A pilot project for the delivery of Advanced Care Directives (Tom Fitch)

38. Selected QOL Mayo Pilot Studies Hospice patient QOL Music and massage therapy interventions Multi-disciplinary psychosocial intervention Triaging patients for psychosocial risk Social support for elderly cancer patients QOL for patients on phase I trials Long-term QOL of prostate cancer survivors

39. WIWI Concept Activities under the third theme of intervention trials for QOL endpoints are primarily Mayo Clinic pilot studies which will be eventually brought into the NCCTG. One concept compares prostate cancer patient quality of life among the three most common treatment modalities. A series of three trials is planned to serve as the definitive phase III testing of the most commonly accepted complementary therapies. Dr. Rummans will carry out a Mayo Clinic pilot study to investigate whether an eight-session multi-disciplinary psychosocial intervention can improve newly diagnosed cancer patients� QOL. Dr. Marlene Frost�s companion study will triage newly diagnosed cancer patients for undue psychosocial distress. Finally there are concepts in development in concert with the patient advocate committee. As an example, we are going to pilot the implementation of a clinical trials buddy system wherein patient advocates and cancer survivors are available to provide training and support to cancer patients. Activities under the third theme of intervention trials for QOL endpoints are primarily Mayo Clinic pilot studies which will be eventually brought into the NCCTG. One concept compares prostate cancer patient quality of life among the three most common treatment modalities. A series of three trials is planned to serve as the definitive phase III testing of the most commonly accepted complementary therapies. Dr. Rummans will carry out a Mayo Clinic pilot study to investigate whether an eight-session multi-disciplinary psychosocial intervention can improve newly diagnosed cancer patients� QOL. Dr. Marlene Frost�s companion study will triage newly diagnosed cancer patients for undue psychosocial distress. Finally there are concepts in development in concert with the patient advocate committee. As an example, we are going to pilot the implementation of a clinical trials buddy system wherein patient advocates and cancer survivors are available to provide training and support to cancer patients.

42. The Six Papers 1) Methods used to date 2) Group versus individual differences 3) Single item versus multi-item 4) Patient, clinician, population perspectives 5) Changes over time 6) Practical considerations for specific audiences MCP, April, May, June 2002

44. QOL III: Translating the science of QOL assessment into clinical practice. An example-driven approach for practicing clinicians and clinical researchers October 2-4, 2003, Scottsdale, Arizona I) what is the value added to the clinician? II) How can clinicians compare the accuracy/precision of QOL data relative to other clinical measures? III) How clinicians can interpret QOL data. IV) How much does it cost to incorporate QOL data? V) How clinicians can apply QOL data formally/systematically.