Understanding Consequences
Research type
Research Study
Full title
True Nth UK Decision Support: Understanding Consequences
IRAS ID
158328
Contact name
LA Brindle
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
At the time when patients are coming to terms with a localised prostate cancer diagnosis, they are faced with complex decisions that involve weighing a number of potential outcomes of treatment. UK NICE Prostate Cancer Guidelines recommend that men with low risk prostate cancer be told about risks and benefits of treatment options in an unbiased manner. However, evidence suggests that even when men are provided with accurate information about treatment and risks, they are likely to be influenced by the way in which treatment options are presented. There is also evidence that patient decision aids (PDAs) can lead to better understanding of consequences, and result in lower decision regret following treatment. NICE has recommended PDAs for men with localised prostate cancer.
The Understanding Consequences Project will develop and test a Programme to improve men’s understandings of the consequences of treatments, support informed decision-making and reduce treatment decision regret. The Programme, for men with low-intermediate risk prostate cancer, will combine interventions known to improve outcomes for patients making preference-sensitive decisions. The programme aims to:
• Develop a clinical training package to improve patient-clinician communication about primary treatment.
• Provide men with audio-recordings of their consultations.
• Implement PDAs within the NHS.
• Signpost men and their families to resources to support decision-making at home.
• Implement the routine use of patient-completed measures of informed consent, and audit referral to PDAs, to improve sustainability within the NHS.The Programme will be developed at two clinical sites and evaluated (tested) at two further sites. The evaluation will compare patients who make treatment decisions over the 6 months prior to the introduction of the Understanding Consequences Programme, with patients entering the Programme over the 6 months after its introduction. The men will be followed for 8 months, with self-completion questionnaires at treatment decision and 8 months later.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0132
Date of REC Opinion
15 May 2015
REC opinion
Further Information Favourable Opinion