Decision making for locally advanced and recurrent rectal cancer V3
Research type
Research Study
Full title
Decision making in pelvic exenteration for locally advanced (LARC) and recurrent rectal cancer (LRRC) - patient and clinician perspectives
IRAS ID
257890
Contact name
Martyn Evans
Contact email
Sponsor organisation
Abertawe Bro Morgannwg University Health Board
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Introduction:\nIn the UK, 14,000 new cases of rectal cancer are diagnosed every year, and 40,000 in the US, of which between 5% and 10% are locally advanced. Locally advanced rectal cancer (LARC) or locally recurrent rectal cancer (LRRC) with contiguous organ involvement is a devastating disease. Radiotherapy and chemotherapy have an important role in palliation and symptom control, but surgical resection involving multivisceral or pelvic exenterative (PE) approach, is the only potential curative treatment. It represents one of the most invasive oncological interventions.\n\nPatients need clear and comprehensive information about the condition and the treatment options to make a legally binding informed decision. Information needs to be based on high quality evidence, outlining outcomes, risks and uncertainties in a clear, comprehensible and unbiased manner which can be delivered using a patient decision aid (PDA). \n\nAim\nThe aim of this study is to develop a PDA for these patients.\n\nMethods\nThe study is designed as a mixed methods project to develop a PDA for patients with LARC or LRRC to evaluate treatment options. Initially a systematic literature review and a review of available literature at various UK centres offering exenterative surgery will be performed. Subsequently a qualitative study using interviews for both patients and clinicians will be undertaken to identify and evaluate influential factors in the decision-making process for treatment. Participants will be recruited from 6 different sites in the UK-London, Swansea, Leeds, Newcastle, Edinburgh and Cambridge. The findings of the systematic review and qualitative interviews will inform he first stage of the development of a PDA which will subsequently be validated by patients and clinicians to assess content validity, usability and comprehensibility.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0056
Date of REC Opinion
11 Apr 2019
REC opinion
Favourable Opinion