1. Quality of Life CBMTG 0801 Investigators’ Meeting 07-Apr-2010

2. QOL Sub-Committee for 0801 Dr. Cynthia Toze (Vancouver General Hospital) Dr. Stephanie Lee (Fred Hutch Centre)

3. “Generic” questionnaires used initially Gradual development of questionnaires specific to oncology, BMT and GVHD 1997 – McQuellon RP, et al (Bone Marrow Transplant) – FACT-BMT 1999 – Hann, et al (Journal of Psychosomatic Research) concluded the CES-D to be valid and reliable in patients with cancer Background on the Questionnaires

4. 2002 – Lee, et al (BB&MT) A chronic GVHD patient self-administered symptom scale (30 item, 7 subscales) was developed and validated Recommendation that this scale be used with another validated QOL instrument (FACT-BMT or Short Form-36)

5. Wong, et al – Blood, 25 March 2010: “Long-term recovery after hematopoietc cell transplantation: predictors of quality of life concerns ” Need for longitudinal QOL studies identified Chronic GVHD is a risk factor for poor QOL post transplant Self reported cGVHD correlates well with medical records

6. Lee, SJ et al (BB&MT) (2002) “Real-time” assessment more accurate than retrospective review Prospective collection of objective lab and medical assessment recommended QOL should be considered an important endpoint in any study of cGVHD intervention

7. The Questionnaires Bradburn FACT-BMT Illness Intrusiveness Scale EQ-5D Socio-demographics Patient cGVHD Severity Scoring Table

8. Bradburn – widely used since 1969 FACT-BMT (1997) – 4 domains (physical, emotional, social, functional) Illness Intrusiveness Scale – Measures the impact of disease and/or treatment on important activities Socio-demographics – complementary information regarding education, income and social support

9. EQ-5D Most commonly used in the European community Developed by a collaborative group from Western Europe known as the EuroQol group. Formed in 1987 A network of international, multi-disciplinary researchers, originally from England, Finland, the Netherlands, Norway, and Sweden

10. Patient Chronic GVHD Severity Scoring Table Developed to reflect the multi-organ manifestations of cGVHD 30 items Responsive to change in severity

11. The Center for Epidemiologic Studies Depression Scale (CES-D) One of the most common screening tests to determine his or her depression quotient The quick self-test measures depressive feelings and behaviours during the past week Fax to Data Management Office as soon as completed

12. Prior studies show interventions may be beneficial when scores are high (15 or greater) Participants need to know that this questionnaire will be scored and that their transplant physician and/or study coordinator will contact them if they are significantly depressed Find your own score: http://counsellingresource.com/quizzes/cesd/ind ex.html http://counsellingresource.com/quizzes/cesd/ind ex.html

13. When

14. Questionnaire Schedule Pre-Conditioning Month 3* Month 6 Month 12 Month 24 ___I_______I_______I______I_______I___ * Patient Chronic GVHD Symptom scale only (repeat at onset of chronic GVHD)

15. The Method Matters!

16. IN GENERAL: Least burdensome is face to face interview Telephone interviews are more tiring Written completion most challenging Discuss method with each participant – Try to use the method they are most comfortable with (Bowling, A. Journal of Public Health, 2005)

18. RADAR R eview the forms A ctive participation D on’t re-phrase A void partner completion R eview directly after