Clinical trials in psychosocial medicine: methodologic and statistical considerations. Part I. Introduction

Psychosocial oncology is defined as a newly developing field which requires its own methodology for measuring the importance of psychologic and social factors for cancer patients, their families, and involved health professionals. As with all new areas of research, there must be a systematic approach once clinical observations and initial hypotheses have been made. The science for such an approach has been slow to develop because of the complexities of finding and testing the appropriate instruments for identifying and quantifying variables before trying to improve the patient's adjustment. In order to facilitate this process, a five-center collaborative group has been formed. Among its first tasks are the selection and testing of screening instruments.