LB37
The QUEST Trial: a multi-centre randomised trial to assess the impact of the type and timing of breast reconstruction on quality of life following mastectomy
Zoe E Winters1, Judith Mills2, Lucy Kilburn2, Rob Horne3, Jennie Hitchins3, Marie Emson2, Judith M Bliss2
1University Hospitals of Bristol NHS Foundation Trust, UK, 2The Institute of Cancer Research, Sutton, UK, 3Centre for Behavioural Medicine, School of Pharmacy, London, UK
Aim
To evaluate Health Related Quality of Life (HRQL) as a primary outcome
measure in women undergoing Latissimus Dorsi breast reconstruction (LDBR)
Background
Breast reconstruction is performed to improve HRQL for women facing
mastectomy, but there is a paucity of high-quality evidence to suggest optimal
type or timing of surgery to guide patients and their surgeons in making
informed decisions regarding their options. This is particularly evident
in the context of post-operative radiotherapy. A randomised clinical trial
(RCT) is required, but as this is a novel approach internationally, a
feasibility study is essential to assess acceptability of randomisation.
Method
Funding has been awarded for a multicentre RCT consisting of two parallel
phase III studies. Study A compares implant-assisted with extended tissue-based
LDBR for women where post-operative radiotherapy is not required; Study B
compares immediate with delayed extended tissue-based LDBR for women where
post-operative radiotherapy is anticipated. Centres can opt to
participate in one study or both.
Results
The trial is currently in set-up with extensive consumer input in relation
to the patient information, the concept of randomisation in this setting and
the study designs. Detailed patient and HCP questionnaires have been designed
to gauge perceptions of equipoise evidence and randomisation.
With increasing rates of breast cancer survival, HRQL is increasingly relevant It is only by an RCT, however that evidence can be produced to allow women to make informed decisions regarding their reconstructive options. An RCT in breast reconstruction is a challenging proposal, but one which is desperately needed.
