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Tailored nurse navigation for women treated for breast cancer: Design and rationale for a pilot randomized controlled trial

Women with breast cancer may experience a number of psychological and physical symptoms during treatment [1]. Although some symptoms attenuate over time, certain patients may have continuously severe symptoms even after the end of treatment [2]. In Denmark, a municipal rehabilitation system is used to help manage such symptoms, in collaboration with hospitals and general practitioners. Nevertheless, breast cancer patients still report that they need support and symptom management [3]. The greatest challenges in cancer care reported by patients, caregivers and care providers are: delay and lack of coordination of care, lack of information and inadequate management of psychological and social problems [4]. Attempts to optimize and integrate cancer rehabilitation have included patient-reported outcomes (PRO) and patient navigation. PROs may improve communication between patients and health professionals [5] and potentially also symptoms [6], but overall only a small-to-moderate effect has been reported on symptoms [7]. Originally, patient navigation was conceived to overcome that African–Americans were diagnosed at a disproportionately later cancer stage than whites, by providing timely medical services by lay health workers [8]. Today nurse navigation often implies being the general patient’s advocate and source of support emphasizing skills in empathic listening, assessing and addressing patients’ symptoms [9]. Three randomized controlled trials (RCTs) have evaluated oncology navigation programs [4,10,11], lay people were used as navigators in one [10] and nurses in the other two [9,11]. Although the studies show positive patient experience and fewer problems in care, none of the studies indicates reduction in patient-reported psychological or physical symptoms, perhaps due to that all women were invited to participate independent of distress level [9,11]. In a previous study, we found that about 40% of the women were distressed already at diagnosis [12–14] and while many are able to manage their symptoms through existing cancer care services, some experienced continuous symptoms. Thus, evidence-based models tested in high-quality RCTs are required for optimal management of these cancer-related symptoms. We describe here the rationale behind the design, delivery and evaluation of a screening-based nurse navigation program for optimizing rehabilitation of women with breast cancer. To justify ethically a large RCT with potential generalizability to the Danish population of women with breast cancer, we decided first to obtain results in a pilot study. Data collection after 12 months’ follow-up will be reported in late 2016. Methods and analysis