Objectives: Prostate cancer (PC) is the most common neoplasia in men over 50 years of age in western countries. Nowadays, since there are several alternative medical-surgical treatments for this cancer, health-related quality of life (HQoL) evaluation has become very important. The present study deals with the development and the validation of a questionnaire (BSP-PC), considering the HQoL in prostate cancer patients. The BSP-PC items are mainly related to the subjects' satisfaction. As far as we know, it does not exist any disease specific instrument based on such aspect.
Materials and methods: Questionnaire development: During three different meetings, with ten experts and twenty patients, we have defined the life aspects which are the most affected by prostate cancer. Subsequently we have created a first 40-item version of the BSP-PC. Patients were asked to fill in this particular questionnaire in addition to a generic and validated one (the EuroQol). A final 24 item questionnaire version, was finally achieved by other statistical analysis and meetings with experts. Questionnaire validation: the BSP-PC was filled in by 261 patients divided into 3 groups: "healthy" (57), "prostate cancer" (103), "other diseases" (100).
Results: Questionnaire development: participants' mean age was 59 years (N=71); 46% had prostate cancer, while 53% of the sample did not report notable diseases. The 24 items were selected on the basis of the following criteria: a) r>0.50, p<0.05 (correlation test re-test), b) p<0.05 (ANOVA presence vs absence of PC), c) r>0.50, p<0.05 (correlation with EuroQol). Questionnaire validation: participants' mean age was 68 years (N=261). Four factors were identified: 1) satisfaction about physical functionality (Crombach alpha=0.95), 2) satisfaction about sexual functionality (alpha=0.94), 3) satisfaction about social functionality (alpha=0.77), 4) satisfaction about urinary functionality (alpha=0.89); total Crombach alpha was 0.94.
Conclusions: The BSP-PC questionnaire can be used as an instrument in the evaluation of HQoL in PC patients by principally considering their subjective satisfaction.