Clinical trial question prompt list

Lead researcher

Professor Martin Tattersall (NSW), Dr Michael Jefford (Vic) & Professor Ian Olver (SA)

Years funded

Surveys of the general public have found widespread support for the concept of clinical trials as an important and ethical means of developing improved medical care. Randomised clinical trials are the gold standard for treatment evaluation, yet trivial proportions of patients enter clinical trials in many institutions that promote clinical trial participation. Patient refusal explains about a quarter of nontrial participation. Even when patients agree to participate in a clinical trial, they frequently do not understand the rationale for the trial. Patients who actively participate in medical consultations by asking questions are able to change the focus of discussion and control the amount of information provided. We have investigated the provision of a question prompt list to cancer patients before their initial consultation with an oncologist. In four separate studies, we have found that provision of the question prompt list increased patients' question asking. When the oncologist endorsed the use of the prompt list, patients' recall of and satisfaction with the consultation was enhanced, and their anxiety level was significantly reduced. We have prepared a question prompt list for patients to facilitate their participation in clinical trial consent discussions. This project aims to investigate the effects of promoting question asking when cancer patients are asked to consider entering a randomised clinical trial. The proposed study will determine whether providing cancer patients with a clinical trial question prompt list when considering clinical trial participation enhances their understanding of the cancer clinical trial and increases their satisfaction with the informed consent and treatment decision making process. This simple intervention may help patients participate more fully in discussions about clinical trial enrolment, and lower their psychological distress.