Psychological factors that influence patient participation in cancer clinical trials

The accrual of patients to cancer clinical trials has been noted by a number of authors as a significant problem. Research to date has examined a range of patient and physician related factors that may account for the low accrual rate. Patient refusal as a reason for non-participation has been found by previous research to account for a significant proportion of patients who are not entered onto a trial. This project aimed to explore the differences in attitudes and psychological variables between patients who refused a clinical trial and those who consented.A cross sectional, single point, postal questionnaire design was employed. Patients who were medically eligible for current phase I, II or III cancer chemotherapy clinical trials received a series of self-report questionnaires. These assessed personality, mood status, emotional expression and health locus of control, and patients' attitudes to research and hypothetical clinical trials. Follow up semi-structured interviews were held with a subsample of participants.During the data collection period, 48 patients were identified as eligible for clinical trials. Of these, 95.9% consented to a trial. The results query previous fmdings that patient refusal is a significant problem in accrual to trials. Thirty-one patients (63%) returned the questionnaires and of these, none refused entry to a clinical trial. Statistical analyses showed that patients' attitudes to research were related to their willingness to enter hypothetical clinical trials. An effect of personality and health locus of control on patients' perception of choice when offered a trial was found. Qualitative analysis revealed that the decision to enter a clinical trial was not difficult for patients, as hadbeen previously proposed. Recruitment and methodological difficulties are discussed