A randomised controlled trial of an audiovisual patient information intervention in cancer clinical trials

摘要: Introduction and background Recruitment to cancer clinical trials needs be improved, as does patient understanding about trials, enable patients make an informed choice whether or not take part. The main reason that clinically eligible do part in is because they refuse; poor of the research has been associated with refusal. Audiovisual information (AVPI) shown improve knowledge/understanding various areas practice but there limited its effect trial setting, particularly relation recruitment rates. Understanding necessary for consent, it was hypothesised if increased AVPI, then this could result a reduction number refusing therefore provide ethical approach improving recruitment. This study aimed test impact audiovisual intervention on randomised (refusal rates), given, levels anxiety. Reasons patients’ decisions participation were also assessed. Method An AVPI developed address common misconceptions randomisation equipoise, well generally other core informational requirements, such voluntariness. Patients receive either addition standard trial-specific written information, alone. A new questionnaire assess (also referred knowledge) setting and, following testing nurses, reliable valid. completed self-report questionnaires their (new knowledge questionnaire) anxiety (Spielberger State-Trait Anxiety Inventory), at baseline after had made decision entry, when perceptions intervention, factors contributing determined (this tool incorporated Jenkins Fallowfield’s (2005) which assessed reasons accepting declining trials). Results total 173 breast (65%), colorectal (32%) lung (3%) entered into study. median age 60 (range 37-92 years). There no difference rates between two groups: 72.1% group 75.9% group. estimated odds ratio refusal (intervention/no intervention) 1.19 (95% ci 0.55-2.58, p=0.661). Knowledge scores more compared (U= 2029, p=0.0072). change score arms statistically significant (p=0.011) arm than nointervention arm. groups –4.6 –7.0 –2.0). Clinical entry influenced by tumour type, stage cancer, age, educational qualifications previous experience, however, modest association deprivation status (p=0.046) where affluent least likely consent trial. Educational independently knowledge: who better educated higher advanced cancer. Acceptability high 93% those watched finding useful, 42% stating them want Personal benefit altruism key motivating participation, being less clear. Discussion conclusions Although potential increase highlighted literature, study, have any trials. However, prior making, useful process addresses fundamental challenges understanding, supports framework integral Faden Beauchamp’s (1986) theory consent. sensitive effective instrument measuring although would from further testing. appears reduce making time point acceptable medium patients. confirms existing findings studies assessing affecting personal factors, need qualitative work area gain deeper what important patients, terms why refuse participation. Implications Several implications identified, including using package considering focussing staff education area. introduced routine determine allowing clinicians opportunity correct Further specific individual helpful, customised importance studying aspects interaction clinician patient, detailed exploration highlighted.