Abstract
BackgroundFew studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials. However, integrated qualitative studies in such trials are needed to enable a broader evaluation of patient experiences in the trial, with important ethical and practical implications for the design and conduct of similar trials and treatment regimes in the future.MethodsTen participants were recruited from the control and intervention arms of FRAGMATIC: a non-placebo trial for patients with advanced lung cancer. Participants were interviewed at up to three time points during their time in the trial. Interviews were analysed using Interpretive Phenomenological Analysis.ResultsPatients were motivated to join the trial out of hope of medical benefit and altruism. Understanding of randomisation was mixed and in some cases poor, as was appreciation of trial purpose and equipoise. The trial was acceptable to and evaluated positively by most participants; participants receiving the intervention focused on the potential treatment benefits they hoped they would receive, whilst participants in the control arm found alternative reasons, such as altruism, personal fulfilment and positive attention, to commit to and perceive benefits from the trial. However, whilst experiences were generally very positive, poor understanding, limited engagement with trial information and focus on treatment benefits amongst some participants give cause for concern.ConclusionsBy exploring longitudinally the psychological, emotional and cognitive domains of trial participation, we consider potential harms and benefits of participation in non-placebo trials amongst patients with advanced lung cancer and identify several implications for future research with and care for patients with advanced cancer.Trial registrationISRCTN80812769. Registered on 8 July 2005.
Highlights
Few studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials
Embedded qualitative studies in clinical trials allow a much more in-depth investigation of participants’ experiences and perspectives than can be captured in these kinds of structured questionnaires [9], and they are necessary for capturing the wider benefits or harms that trial participation may bring to patients, including psychological and emotional impacts
The reported findings derived from this qualitative substudy complement the results of the main FRAGMATIC trial and contribute to the wider literature on clinical trials with patients with advanced cancer
Summary
Few studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials. Embedded qualitative studies in clinical trials allow a much more in-depth investigation of participants’ experiences and perspectives than can be captured in these kinds of structured questionnaires [9], and they are necessary for capturing the wider benefits or harms that trial participation may bring to patients, including psychological and emotional impacts. This means considering patient understandings, expectations and motivations; how patients experience the intervention itself; and what else people get out of trials if not direct medical benefits. Such findings can be used to help improve the design and delivery of future trials, treatments and services, or, as is the case in one of our current studies, they can be presented in real time to inform trials which are on-going [10]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
