1. Background Communication with patients contemplating early phase cancer trial participation can be challenging. It is an ethical imperative that consent is given freely and that it is both informed and educated. Controversy exists as to whether or not patients are provided with information that is comprehensive enough to permit truly informed consent 1. Even if communication is appropriate, appreciation of other factors motivating trial entry is important. We present data from a larger CRUK funded communication study 2 examining the reasons patients gave for accepting or declining Phase I/II trials. What reasons do patients give for declining or participating in early phase cancer trials? Susan Catt 1, Carolyn Langridge 1, Valerie Jenkins 1, Denis Talbot 2, Lesley Fallowfield 1 1 CRUK Psychosocial Oncology Group, Brighton & Sussex Medical School 2 University of Oxford Medical Oncology Unit Conclusions Patients considering PI/II trials may be a self-selected group with optimistic expectations for personal benefit helping to drive trial entry. Achieving genuinely informed consent and avoidance of therapeutic misconceptions in such patients might be difficult. A communication skills course informed by these data has been developed (see poster A59). References: 1 Jenkins, V, Anderson, J, Fallowfield, L. 2010 Support Care Cancer, 18 (9):1115-21. 2 Jenkins, Solis-Trapala, Langridge, Catt, Talbot, Fallowfield. 2010 Journal of Clinical Oncology (in press) Acknowledgements: Cancer Research UK funded this work. We thank all patients who participated. Results most (92%) of patients accepted trial entry only 4 declined which is too small for statistical analysis. The prime reason given was fear that participation would detract from quality of life (see box below) overall patients had optimistic personality traits, though lower optimism was significantly associated with probable psychological morbidity Statements about trial participation Patients frequency of agreement to statements on the accept - decline measure showed that: 90-98% agreed they had sufficient trial information most (96%) placed their trust in the doctor treating them three quarters expected to derive medical benefit from the trial 85% did NOT feel unable to say no to the trial 83% agreed joining the trial would give them hope a quarter worried about being a guinea pig few (13%) had concerns about trial burdens Main factors motivating trial entry Patients nominated their main reason for accepting trial entry these are displayed in the chart below (n=45). ID 16 Now back with my husband, moving back to Wales to make the most of whatever time I have left. ID 20 Quality of life is far more important than quantity. frequency Method Following discussions with oncologists about PI/II trials patients completed 3 questionnaires. 1) Accept – Decline Questionnaire a 19 item study specific tool measuring:- hope and expectations of benefit altruism pressures to participate concerns about the trial general perceptions of trial information provided 2) General Health Questionnaire (GHQ12) 3) Life Orientation Test (LOT-R) Sample n=49 ( * =1 missing data) Sex (M/F) Age mean (sd) Education* - no exams O/A levels University Employed* (yes/no) Married* (yes/no) Cancer site - Colorectal/upper GI Skin Breast Gynaecological Other Past trial experience (yes) LOT-R mean (sd) GHQ12* (above/below case threshold) Sample 30 (61%) / 19 (39%) 58 yrs (10.59) 17 (36%) 15 (31%) 16 (33%) 16 (33%) / 32 (67%) 36 (75%) / 12 (25%) 25 (52%) 8 (16%) 6 (12%) 5 (10%) 18 (37%) 15.53 (3.44) 23 (48%) / 25 (52%)