Background

1. Attitudes of 1066 cancer patients in Wales towards medical research and RCTs Lesley Fallowfield1, Daniel Farewell2, Carolyn Langridge1, Louise Parlour1, Tim Maughan3, Libby Batt3, Lucy Branston3, Vern Farewell4, Valerie Jenkins1 1 Cancer Research Psychosocial Oncology Group, Brighton & Sussex Medical School, University of Sussex 2 Cardiff University School of Medicine, UHW Main Building, Heath Park, Cardiff 3 NISCHR CRC/ Wales Cancer Research Network Cardiff  4 MRC Biostatistics Unit, Institute of Public Health, University Forvie Site, Cambridge Background Background A) The number of potentially eligible patients recruited to randomised clinical trials (RCTs) worldwide is low. Trials often fail to recruit target numbers or take too long. This impedes collection of research evidence and delays the early introduction of efficacious treatments into the clinic. Barriers to recruitment are multifactorial and include failure to identify eligible patients, reluctance of staff to approach them and the attitudes of some healthcare professionals towards trials. In this study we have assessed the attitudes of patients towards RCTs as part of a larger prospective study aimed at improving communication, involvement and attitudes of multidisciplinary cancer teams in Wales. Sample and Method B) Clinic staff in oncology outpatient departments across Wales identified patients who were then invited by an independent researcher to complete the Attitudes to Randomised Trials Questionnaires (ARTQ)1. 1070/1146 (93%) patients completed the questionnaire and 1066 questionnaires were suitable for analysis. C) The 7-item ARTQ measures a positive or D) negative inclination toward:- (i) medical research in general; (ii) a personal willingness to be involved in research; (iii) personal involvement in research involving randomisation. Results F) Those who answered ‘No’ or ‘Don’t know’ to Q3 (n=477) were given 3 further pieces of information explaining: i) that either treatment was completely suitable ii) that they could leave the study if the treatment did not suit iii) that plenty of information would be given before the random choice was made We asked: Would all these things together change your mind and agree to take part? E) Q1) Do you think that patients should be asked to take part in medical research? Q2) Would you be prepared to take part in a study comparing different treatments? Q3) Would you be prepared to take part in a study where treatment was chosen at random? Conclusions Overall acceptance to trials: n=886 (83%) G) H) The majority of patients were receptive to RCT participation. Many of those initially put off by randomisation would consider joining if given further details that form part of standard GCP consent guidelines. These data show the importance and need for clear communication and information to encourage RCT participation. Evidence based training courses are available to assist with this. • Randomisation initially deterred many patients from endorsing a willingness to participate. However, if information about the voluntary nature and rights to withdraw were provided together with further details about treatment, 83% (886/1066) would potentially participate. • Other variables associated with a positive inclination included: - previous trial experience (p<0.01), sex - men more likely to agree with putative involvement (p<0.01). Patients ≥ 70 years were less likely to consider trial entry (p<0.01). Acknowledgements: Patients and clinic staff. Cancer Research UK funded the study. Ref:1 Fallowfield, Jenkins et al (1998) EJC, 34, 1554-9.