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Background: A patient decision aid (PtDA) can support shared decision making (SDM) in preference-sensitive care, with more than one clinically applicable treatment option. The development of a PtDA is a complex process, involving several steps, such as designing, developing and testing the draft with all the stakeholders, known as alpha testing. This is followed by testing in ‘real life’ situations, known as beta testing, and then finalising the definite version. Our aim was developing and alpha testing a PtDA for primary treatment of early stage breast cancer, ensuring that the tool is considered relevant, valid and feasible by patients and professionals. Methods: Our qualitative descriptive study applied various methods including face-to-face think-aloud interviews, a focus group and semi-structured telephone interviews. The study population consisted of breast cancer patients facing the choice between breast-conserving therapy with or without preceding neo-adjuvant chemotherapy and mastectomy, and professionals involved in breast cancer care in dedicated multidisciplinary breast cancer teams. Results: A PtDA was developed in four iterative test rounds, taking nearly 2 years, involving 26 patients and 26 professionals. While the research group initially opted for simplicity for the sake of implementation, the clinicians objected that the complexity of the decision could not be ignored. Other topics of concern were the conflicting views of professionals and patients regarding side effects, the amount of information and how to present it. Conclusion: The development was an extensive process, because the professionals rejected the simplifications proposed by the research group. This resulted in the development of a completely new draft PtDA, which took double the expected time and resources. The final version of the PtDA appeared to be well-appreciated by professionals and patients, although its acceptability will only be proven in actual practice (beta testing)
INTRODUCTION: An optimal relative dose intensity (RDI) of adjuvant chemotherapy is associated with better survival in patients with breast cancer. Little is known about the role of physical fitness in attaining an adequate RDI in patients with early stage breast cancer. We investigated the association between pre-treatment physical fitness and RDI in this population.METHODS: We pooled individual patient data from two randomized exercise trials that studied exercise programs in early breast cancer: the PACES (n = 230) and the PACT (N = 204) study. Logistic regression models were used to evaluate the association between pre-treatment fitness and achieving an optimal RDI (≥85%). In addition, we added an interaction term to the model to explore the potential moderating effect of participating in an exercise program.RESULTS: Data were available for 419 patients (mean age at diagnosis 50.0 ± 8.6 years). In the total sample, lower pre-treatment physical fitness was associated with significantly lower odds of achieving ≥85% RDI: age-adjusted OR 0.66 [95%CI 0.46-0.94]. In patients allocated to the supervised exercise intervention during chemotherapy (n = 173), the association between pretreatment physical fitness and RDI was almost completely mitigated (OR 0.95 (95%CI 0.54-1.56)), while it was more pronounced in patients who received care as usual (n = 172, OR 0.31 (95%CI 0.13-0.63) pinteraction: 0.022).CONCLUSION: Early stage breast cancer patients with relatively lower levels of pretreatment physical fitness have lower odds of achieving an optimal dose of chemotherapy. Given that physical fitness is modifiable and our results suggest that following a moderate-to-high intensity exercise training during chemotherapy could improve treatment completion, clinicians should not refrain from referring patients to supportive exercise programs because of low fitness.
MULTIFILE
Background: The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients’ informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to β test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting. Methods/design: This paper concerns a preimplementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid.