The Library
Involving patients in clinical trial design : the experience of the UK Ibreast early breast cancer follow-up trial
Tools
Dunn, Janet A., Wilcox, M., Taggart, Frances M., Hulme, Claire, Tritter, Jonathan, Austoker, Joan, Mossman, Jean, Fide, Jane, Balmer, Claire E., Beaver, Kinter and Donnelly, Peter (2009) Involving patients in clinical trial design : the experience of the UK Ibreast early breast cancer follow-up trial. In: Society for Clinical Trials Annual 30th Annual Meeting 2009, Atlanta, Georgia, USA, 2009
Research output not available from this repository.
Request-a-Copy directly from author or use local Library Get it For Me service.
Abstract
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.
Item Type: | Conference Item (Poster) | ||||
---|---|---|---|---|---|
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > ( - July 2016) Health Education Hub Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
||||
Official Date: | 2009 | ||||
Dates: |
|
||||
Status: | Not Peer Reviewed | ||||
Conference Paper Type: | Poster | ||||
Title of Event: | Society for Clinical Trials Annual 30th Annual Meeting 2009 | ||||
Type of Event: | Conference | ||||
Location of Event: | Atlanta, Georgia, USA | ||||
Date(s) of Event: | 2009 | ||||
Related URLs: |
Request changes or add full text files to a record
Repository staff actions (login required)
View Item |