A multi-centred study of the effectiveness of PEGASUS
Research type
Research Study
Full title
A multi-centred study of the effectiveness of PEGASUS, an intervention to promote shared decision making about breast reconstruction
IRAS ID
174931
Contact name
Diana Harcourt
Contact email
Sponsor organisation
University of the West of England, Bristol
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Each year more than 15,000 women in the UK undergo a mastectomy operation. Loss of a breast is a distressing experience, with potential for a substantial negative impact on well-being, quality of life and body image. Breast reconstruction refers to a range of surgical procedures that recreate a breast shape for women who have undergone mastectomy. Each year around 4,000 women in England elect to have reconstruction after mastectomy, but making this decision can be difficult and complicated because there are numerous, complex options. Furthermore, many women who do undergo breast reconstruction report that the outcome of surgery did not meet their expectations, which itself can have a negative psychological impact. In 2011 we developed PEGASUS, a new way to support women choosing whether or not to have reconstructive surgery, by helping them to be clear about their expectations and goals so that surgeons can address any unrealistic expectations before surgery takes place.
This study will compare 2 groups of women – 90 that use the PEGASUS intervention and 90 that do not, so that we can assess whether it offers measurable differences to their reports of satisfaction with care and the outcome of surgery, body image, quality of life and involvement in decision making. The study will take place across 4 hospitals in the South West of England. This project aims to establish whether women who receive the PEGASUS intervention are more satisfied with the outcome of breast reconstructive surgery and their involvement in decision making about surgery than are women who do not receive PEGASUS before making their decision. It will also evaluate any economic implications of using the intervention.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0331
Date of REC Opinion
1 Jul 2015
REC opinion
Further Information Favourable Opinion