Abstract: PD06-05
Sources of Funding: Prostate Cancer Foundation of Australia and Royal Australian and New Zealand College of Radiologists Research Grant.

Introduction

Randomised controlled clinical trials are considered the ‘gold-standard’ for evaluating medical treatments. However, recruitment to clinical trials is low overall, with both patients and clinicians reporting difficulties with the consent process. Decision Aids DAs)may improve this process by ensuring patients weigh up the pros and cons of all their options and make informed value-sensitive decisions. We aimed to evaluate the utility of a DA for potential participants of a prostate cancer clinical trial (Trans-Tasman Radiation Oncology Group’s RAVES 08.03), in reducing decisional conflict, improving knowledge and potentially improving informed trial recruitment.

Methods

Potential participants for RAVES were identified by their urologist or radiation oncologist (RO) and invited to participate in the DA study. Participants received a pre-randomised package containing the standard RAVES participant information sheet and either the custom developed DA or a blank notebook. The packages were identical in appearance and both participant and recruiting clinician were blinded to the intervention. Questionnaire measures of decisional conflict and knowledge (including RAVES knowledge) were administered at baseline, one and six months. The primary outcome measure was decisional conflict. Secondary outcomes measured included knowledge about clinical trials and RAVES as well as recruitment to RAVES.

Results

127 men (median age = 63 years) were recruited through urologists (n = 91) and radiation oncologists (n = 36). 61 men were randomised to the DA arm and 66 to the control arm. Decisional conflict was significantly lower (p = 0.0476) and knowledge regarding RAVES was significantly higher (p = 0.033) in the DA arm. 18% of the DA arm (11 of 61) and 9% of the control arm (6 of 66) were recruited to RAVES. This difference did not reach statistical significance. Of the 5 men from the urologist sample who subsequently entered RAVES (5.5%), all 5 were from the DA arm (p=0.017). Of the 11 men from the RO sample who subsequently entered RAVES (30.5%), there was no significant difference in recruitment by the DA intervention.

Conclusions

This study is the first to demonstrate the utility of a DA in reducing decisional conflict and improving trial knowledge in men making decisions regarding a prostate cancer clinical trial participation. The DA also improved trial recruitment in a sub-group of patients.

Funding

Prostate Cancer Foundation of Australia and Royal Australian and New Zealand College of Radiologists Research Grant.