Abstract
BackgroundNeoadjuvant systemic therapy is offered to selected women with large and/or highly proliferative operable breast cancers. This option adds further complexity to an already complex breast cancer treatment decision tree. Patient decision aids are an established method of increasing patient involvement and knowledge while decreasing decisional conflict. There is currently no decision aid available for women considering neoadjuvant systemic therapy.ObjectiveWe aimed to develop a decision aid for women diagnosed with operable breast cancer and considered suitable for neoadjuvant systemic therapy, and the protocol for a multicenter pre-post study evaluating the acceptability and feasibility of the decision aid.MethodsThe decision aid was developed through literature review, expert advisory panel, adherence to the International Patient Decision Aid Standards, and iterative review. The protocol for evaluation of the decision aid consists of the following: eligible women will undertake a series of questionnaires prior to and after using the decision aid. The primary endpoint is decision aid acceptability to patients and investigators and the feasibility of use. Secondary endpoints include change in decisional conflict, participant knowledge, and information involvement preference. Feasibility is defined as the proportion of eligible participants who use the decision aid to help inform their treatment decision.ResultsThis study has recruited 29 out of a planned 50 participants at four Australian sites. A 12-month recruitment period is expected with a further 12-months follow-up.ConclusionsThe decision aid has the potential to allow patients with operable breast cancer, who have been offered neoadjuvant systemic therapy, decreased decisional conflict, and greater involvement in the decision. If this study finds that an online decision aid is feasible and acceptable, it will be made widely available for routine clinical practice.Trial RegistrationAustralian and New Zealand Clinical Trials Registry ACTRN12614001267640; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614001267640&isBasic=True (Archived by WebCite at http://www.webcitation.org/6gh7BPZdG)
Highlights
Neoadjuvant systemic therapy (NAST) has become a routine treatment option for selected women with operable breast cancer, endorsed by international guidelines [1, 2], patients [3], doctors [4], and breast cancer advocates [5]
If this study finds that an online decision aid is feasible and acceptable, it will be made widely available for routine clinical practice
We describe the development of such a decision aids (DA) and the protocol for a study that will evaluate that DA
Summary
A DA (see Multimedia Appendix 1) was developed based on a literature review and refined in an iterative process by an expert advisory panel comprising medical oncologists, breast surgeons, a psycho-oncologist, consumers, a breast care nurse, and a breast cancer advocacy organization representative according to the systematic process described by Coulter et al [24]. The structure of the DA was based on the International Patient Decision Aid Standards Collaboration statement, to include a balanced description of adjuvant and neoadjuvant therapy, including advantages and disadvantages, outcome probabilities for each option, graphics, and a values clarification exercise. The final DA includes an introduction, brief general information about breast cancer and the treatments used, explanation of the options for the timing of chemotherapy and surgery, the advantages and disadvantages of neoadjuvant and adjuvant therapy, a values clarification exercise, a page for notes, a glossary, and information about where to find additional resources. The probability of remaining alive and free of breast cancer at 5 years is presented, based on whether a pathological complete response was achieved, or not. JMIR Res Protoc 2016 | vol 5 | iss. 2 | e88 | p. 3 (page number not for citation purposes)
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