Prospective multi-center study of the impact of the 21-gene recurrence score assay on patient satisfaction, anxiety and decisional conflict for adjuvant breast cancer treatment selection. (Abstract 1092)
This study presented at the recent San Antonio Breast Cancer Symposium in December of 2007 measured Oncotype DX’s impact on treatment decision making, by conducting baseline and follow-up surveys before and after the study participants got the Oncotype DX test. Specifically, the study was designed to capture these patients’ perceptions of treatment recommendations, factors important to treatment choice, perceived risk of disease recurrence, and the influence of the Oncotype DX Recurrence Score on decision making. The Decisional Conflict Scale (DCS) 4 was used to assess perceptions of personal uncertainty in making healthcare decisions, as well as to determine patients’ satisfaction with treatment decision making. The State-Trait Anxiety Inventory (STAI) 5 was also used to measure anxiety “right now.” Measures of anxiety levels and decisional conflict demonstrated a statistically significant improvement (p=0.001) after the Recurrence Score was revealed to the patients.
According to this abstract, patients in this study were open to having the Oncotype DX test, understood the Recurrence Score results, and felt the results were an aid to their treatment decision making. This was determined by using The Patient Treatment Decision Making Questionnaires, which were comprised of brief baseline and follow-up questionnaires that were developed specifically for use in this study to assess the following:
- Patients’ perceptions of treatment recommendations
- The factors important to patients’ treatment choices
- Patients’ perceived risk of recurrence, and the influence of the Recurrence Score on decision making
Results of the Recurrence Score were associated with a change in self-reported choice of treatment for 27% of the women, with the largest treatment change from chemo-hormonal therapy to hormonal therapy alone. Patients reported statistically significant lower levels of conflict about the decision for adjuvant treatment, greater satisfaction with decision making, and decreased situational anxiety after learning the results of the Oncotype DX test. A patient’s perceived risk of recurrence was an important factor in her choice of treatment, and the information provided by the Recurrence Score addresses this concern directly.