Body image is an important endpoint in quality of life evaluation since can
cer treatment may result in major changes to patients' appearance from disf
iguring surgery, late effects of radiotherapy or adverse effects of systemi
c treatment. A need was identified to develop a short body image scare (BIS
) for use in clinical trials. A 10-item scale was constructed in collaborat
ion with the European Organization for Research and Treatment of Cancer (EO
RTC) Quality of Life Study Group and tested in a heterogeneous sample of 27
6 British cancer patients. Following revisions, the scale underwent psychom
etric testing in 682 patients with breast cancer, using datasets from seven
UK treatment trials/clinical studies. The scale showed high reliability (C
ronbach's alpha 0.93) and good clinical validity based on response prevalen
ce, discriminant validity (P < 0.0001, Mann-Whitney test), sensitivity to c
hange (P < 0.001, Wilcoxon signed ranks test) and consistency of scores fro
m different breast cancer treatment centres. Factor analysis resulted in a
single factor solution in three out of four analyses, accounting for > 50%
variance. These results support the clinical validity of the BIS as a brief
questionnaire for assessing body image changes in patients with cancer, su
itable for use in clinical trials. (C) 2001 Elsevier Science Ltd. All right
s reserved.