Approximately half of all newly-diagnosed patients with breast cancer are affected with estrogen-receptor positive, early-stage disease. Clinical guidelines for these women integrate genomic tumor profiling tests such as the Oncotype DX Recurrence Score to refine recurrence estimates and systemic therapy selection when combined with existing markers. Guidelines suggest that the 25% with a high Score benefit from chemotherapy and the 50% with a low Score can safely avoid chemotherapy. While the NCI-funded TAILORx trial has provided prospective validation of the utility of low-risk test results, the primary trial objective is to determine the appropriate use of chemotherapy for the >25% of women who receive intermediate recurrence Scores (for whom the benefits of chemotherapy are unclear). Many challenges remain to maximize the benefits of testing as we await these trial results in the next year. For example, many women have a poor understanding of their Recurrence Score and its impact of treatment selection. Further, our data suggest that, along with distress, patient's pretesting preferences for chemotherapy are a powerful driver of treatment utilization, predicting treatment received over and above the effect of the Score. This suggests that preferences remain stable, even following disclosure and discussion of test results that should guide treatment selection. Finally, tested patients who do not take an active role in their care and report poorer communication by their oncologist are at risk for higher distress and poorer quality of life. Strong clinical communication can impact proximal outcomes of patient comprehension, treatment preferences and satisfaction, involvement in care decisions as well as longer-term outcomes of treatment adherence and QOL. These proximal outcomes can be influenced by patient activation interventions utilizing a question prompt list (QPL). In the context of patients receiving Oncotype DX testing, our QPL could allow them to better understand the rationale for their oncologist's treatment recommendation, what it means for managing their disease, and encourage alignment of treatment preferences and selection with the Recurrence Score. Guided by Street et al.'s model of communication, we propose research in two phases to test the feasibility and impact of our QPL. In Phase 1, we will further refine our draft QPL based on in-depth interviews with patients (N=20) and medical oncologists (N=10). In Phase 2, we will conduct a single-arm trial (N=75) to demonstrate feasibility and preliminarily assess the impact of the QPL on key outcomes.
Our aims are to examine intervention feasibility, evaluate intervention effects on comprehension and treatment preferences, and assess potential intervention mechanisms on comprehension, preferences and satisfaction. We will explore variation in our outcomes across Aims 1-3 based on patient and provider sociodemographics, patient-provider concordance, and patient's language preference. We will achieve our aims by incorporating patient self-report data with observational coding of audiorecordings of clinical encounters in which the Score is integrated with treatment plans. Our intervention and mixed-method approach to assessment will directly inform how test results influence care received by thousands of women.
/Relevance: The purpose of this study is to assess the feasibility and efficacy of a Question Prompt List to support patient-provider communication regarding genomic tumor profiling for breast cancer.
