The attitudes of 1066 patients with cancer towards participation in randomised clinical trials.
BACKGROUND
barriers to randomised clinical trial (RCT) recruitment include failure to identify eligible patients, reluctance of staff to approach them and attitudes of some health-care professionals and patients. As part of a larger UK prospective study examining the communication and involvement in RCTs of 22 multidisciplinary teams in Wales, we also assessed the attitudes of patients they treat towards trials.


METHODS
out of 1146 patients attending outpatient departments who were approached, 1146 (93%) completed the seven-item Attitudes to Randomised Trials Questionnaire (ARTQ), probing their general attitudes towards medical research and likely participation in a hypothetical two-arm RCT.


RESULTS
randomisation initially deterred many patients from endorsing a willingness to participate. However, if information about the trial logic, voluntary nature and rights to withdraw were provided, together with further treatment details, 83% (886 out of 1066) would potentially participate. Other variables associated with a positive inclination towards participation included previous trial experience (P<0.01), male gender (P<0.01) and younger age, with patients > or =70 years less likely to consider trial entry (P<0.01).


CONCLUSIONS
the majority of patients were receptive to RCT participation. Many of those initially disinclined because of 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.
Cancer Research Psychosocial Oncology Group, Brighton & Sussex Medical School, University of Sussex, Sussex, UK. val@sussex.ac.uk
V
V
Jenkins
D
D
Farewell
L
L
Batt
T
T
Maughan
L
L
Branston
C
C
Langridge
L
L
Parlour
V
V
Farewell
L
L
Fallowfield
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001290:Attitude; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D011795:Surveys and Questionnaires