Co-development of a consensus-based pathway to improve access and outcomes for women seeking flat symmetry as an alternative to breast reconstruction after mastectomy for breast cancer: Protocol for the UK FLAME study.

introductionUp to 40% of women with breast cancer will require a mastectomy, and breast reconstruction is routinely offered to restore symmetry. While not all women want, or are suitable for, breast reconstruction, many want to be symmetrical following breast cancer surgery. For these women, contralateral mastectomy for 'flat symmetry' is a good alternative, but in the UK, access to contralateral 'symmetrising' mastectomy (CSM) is highly variable. Many women seeking this option describe feeling frustrated, unsupported and having to 'fight' to access care, while clinicians express concerns about decisional regret. The FLAME (FLat symmetry After Mastectomy for brEast cancer) study aims to work with key stakeholders to co-develop a consensus-based pathway to improve access and outcomes for women seeking CSM as an alternative to breast reconstruction after a unilateral mastectomy for breast cancer. METHODS AND ANALYSIS: Pathway development will be underpinned by the Medical Research Council (MRC) framework for the development of complex interventions, informed by the Behaviour Change Wheel and Capability, Opportunity, Motivation-Behaviour framework, complemented by Intervention Mapping. There will be six key stages: (1) creation of a logic model of the issues that need to be addressed with the CSM pathway using a systematic literature review, national practice surveys and qualitative interviews with key stakeholders; (2) definition of the logic model of change objectives (performance objectives, change determinants and change objectives); (3) pathway design informed by appropriate behaviour change techniques; (4) co-development of the pathway in a co-design workshop involving key stakeholders; (5) co-development of an implementation plan and (6) future evaluation. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the University of Bristol Research Ethics Review Committee (ref: 27961). Written and verbal informed consent will be obtained from all participants before the interview study and again from individuals participating in the workshop. Findings will be presented at national/international meetings and published in peer-reviewed journals. Dissemination materials will be co-produced with key stakeholders and shared widely with professional associations and patient support organisations to promote uptake and implementation.