Involving patients in clinical trial design : the experience of the UK Ibreast early breast cancer follow-up trial

The UK National Cancer Research Institute (NCRI) has made great strides towards fully engaging people in the design, delivery and interpretation of clinical trials. NCRI have consumer representatives on their clinical studies groups. Involvement of consumers at the design stage can considerably improve the trial. The ibreast trial used consumer involvement to focus on the important outcomes, optimise the trial design and gauge feasibility and acceptance of the proposed trial. Ibreast will determine whether innovative alternative follow-up methods (without clinical examination) are equivalent to traditional specialist hospital based follow-up (with clinical examination) in terms of survivorship and patient perception of living with cancer, and provide education and training packages for the alternative follow-up methods. Currently patients are followed-up for 5-years or more within the hospital setting with specialist clinical examination, placing a huge burden on breast cancer services. NICE 2002 guidelines recommend that asymptomatic breast cancer patients who have undergone curative treatment should not have follow-up for more than 3 years after diagnosis but a recent survey indicated that only 8% of specialist breast care practitioners followed these guidelines (Donnelly, 2007). Several pilot studies have attempted to evaluate alternative follow-up models (Grunfeld 2006, Beaver 2005, Vaile 2006, Wishart 2008, Montgommery 2008) but these are underpowered to detect disease-driven-endpoints such as disease-free-survival. The impact of involving consumers in the trial design stage and hosting a breast cancer follow-up workshop of healthcare professionals, patients and consumers will be discussed. Patients need continuity of care and a choice in their management. Trial design issues which professionals debate are often meaningless to the patients who ultimately want optimal treatment of their cancer and a clear message towards what to expect in the future. The need for consumer involvement is demonstrated by the evolution of the ibreast proposal through the design stage.