||5R21CA201827-02 Interpret this number
||A Question Prompt List to Promote Communication in Genomic Medicine
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.
Question Prompt List to Support Patient-Provider Communication in the Use of the 21-Gene Recurrence Test: Feasibility, Acceptability, and Outcomes.
, Vadaparampil S.T.
, Eggly S.
, Street R.L.
, Foster Moore T.
, Isaacs C.
, Han H.S.
, Augusto B.
, Garcia J.
, Lopez K.
, et al.
JCO oncology practice, 2020 Oct; 16(10), p. e1085-e1097.