1. A QUALITY OF LIFE (QOL) QUESTIONNAIRE, CARE NOTEBOOK, FOR CANCER PATIENTS USING OUTPATIENT CLINIC. T. Kobayashi, K. Kobayashi, M. Kobayashi, M. Shimonagayoshi, Kanemoto N, Kasai R, Itoh Y, Ohashi Y, Green J, Gotay CC. Saitama Cancer Center, Saitama, Tokyo University, Tokyo, Japan, Hawaii Cancer Center, Hawaii

2. Aim We have developed Japanese versions of EORTC QLQ-C30 and FACT-G in cooperation with EORTC and CORE, respectively (Eur J Cancer, 34:810, 1998, QOL Research, 10:701, 2001). These questionnaires are available, and used in clinical studies in Japan. However, in the fields of daily clinic and palliative care, we had no tools to measure QOL. In this study, a QOL questionnaire, Care Notebook, was developed and validated.

3. Care Notebook (version 3.0) The questionnaire was designed for outpatients with cancer who were treated by both active treatment and palliative care. Initially items for the questionnaire were derived by clinical oncologists, oncology nurses and cancer patients themselves with discussions. Only twenty four items that seemed to influence daily life of patients were selected. Each item is questioned by one word or a short phrase and employs 11-point linear analogue scale, resulting in good acceptability when self-administered or a minor effort when a paramedical staff helps to cite it.

4. Following clinical practice, 10 items, 6 items and 8 items concerning Physical Well-Being, Mental Well-Being and Life Well-Being, respectively, were listed in the order. a) In terms of Physical Well-Being, symptoms those cancer patients often experience and are resolved by medical treatments are listed. b) In Mental Well-Being, psychological conditions of anxiety, depression, irritability, anger and confusion are entirely listed. c) Life Well-Being was divided into three subscales (Daily Functioning, Social Functioning, and QOL Functioning which has 4 items concerning of global QOL, its satisfaction, happiness and spirituality). While, the questionnaire has a free comment column if a patient wants to communicate with medical staffs. Care Notebook has several prints of the questionnaire, each of which can be separated from the notebook and filed, for example, in patient’s records.

5. English translation is tentative. Care Notebook is got from http://homepage3.nifty.com/care-notebook/.http://homepage3.nifty.com/care-notebook/

6. Methods Cancer patients who used the outpatients clinic of Saitama Cancer Center in March 2001 answered the Care Notebook, EORTC QLQ-C30 and FACIT-Sp twice at 4 week interval. Scales and subscales were extracted by a dendrogram using the VARCLUS procedure on SAS program, and were confirmed by the multitrait-scaling analysis. Internal consistency was checked by Crohnbach’s alpha and test-retest reliability was tested by Peason’s correlation. In terms of clinical validity, known comparison with PS was estimated by t-test. Concurrent validity with QLQ-C30 and FACT-Sp was tested by Peason’s correlation coefficients.

7. Patients characteristics (n=266) Of the 266 cancer patients who used our outpatients clinic center in March 2001, 17 patients rejected to answer the questionnaires.

8. A dendrogram showed three major scales (Physical Well- Being, Mental Well-Being and Life Well-Being) at a level of 0.55 of proportion of variance explained. At 0.75 of that, Life Well- Being was divided into three subscales (Daily Functioning, Social Functioning, and QOL Functioning which has 4 items concerning of global QOL, its satisfaction, happiness and spirituality). DENDROGRAM

9. Convergent & discriminant validity Multitrait scaling analysis The rate of scaling error was 0 % (0 / 126) and 2.4 % (3/126) in convergent and discriminant validity, respectively. Multitrait scaling analysis confirmed convergent and discriminant validity of the three major scales and the subscales.

10. Reliability Internal consistency by Cronbach's alpha and test-retest reliability showed favorable results. # Peason’s correlation coefficients

11. Clinical validity -Known-groups comparison with PS- Known-groups comparison showed the expected clinical validity with PS.

12. Concurrent validity with QLQ-C30 & FACIT-Sp * PF, physical functioning; RF, role functioning; EF, emotional functioning; SF, social functioning; QL, a global quality of life ** Peason’s correlation coefficients Concurrent validity with QLQ-C30 and FACT-Sp was satisfied except for Social Functioning subscale, the content of which is different from SF on QLQ-C30.

13. Conclusion  QOL in outpatients with cancer was operationally defined as three major scales (Physical Well-Being, Mental Well-Being and Life Well-Being).  Life Well-Being was constructed by Daily Functioning, Social Functioning, and QOL Functioning.  “ Life Well-Being” scale was important to cancer patients using outpatient clinic and Care Notebook was found to be valid and useful to these people.