Measurement of factors influencing the participation of patients with prostate cancer in clinical trials: a Canadian perspective.

OBJECTIVE

To identify factors that patients with prostate cancer believe to be important determinants in their decisions about future enrolment in clinical trials.

PATIENTS AND METHODS

In all, 122 patients (within 5 years of a diagnosis of prostate cancer) who had never been asked to participate in a clinical trial were asked to complete a 30-item measure of 'Factors Influencing Participation' in clinical trials.

RESULTS

Factor analysis showed that variables influencing participation can be grouped into three areas: acceptability (e.g. recruitment process and altruistic beliefs); awareness (e.g. impact on quality of life, survivorship and randomization process); and accessibility (e.g. costs to patient, influence of family, age, time and need for extra tests). Awareness items were rated significantly more important by patients with T1 or T2 disease (P = 0.002). Patients who had not made a treatment decision also rated awareness (P = 0.05) and acceptability (P = 0.04) items higher. Patients with less than a university education identified access items as more important (P = 0.03). Helping future patients with prostate cancer, the impact of the study protocol on survival, being fully informed about the study, relationship with specialists, and impact of study on quality of life were identified as the five variables having the most influence on future enrolment.

CONCLUSIONS

Men rated items related to awareness and acceptability as being the most important determinants to future enrolment in a clinical trial. Knowledge about what these men believe is important for their future participation in a clinical trial will help researchers to design protocols that address the needs of targeted patient groups.