Improving patient understanding of GEP test results (IMPARTER4): an RCT.

abstractObjective: Explaining gene expression profiling (GEP) test results to patients can be challenging. We examined the utility of two 8 min films about Oncotype DX and Prosigna to aid the knowledge and decision-making of women with early-stage oestrogen receptor positive (ER+) breast cancer. Methods and analysis: Patients awaiting GEP test results completed an anxiety questionnaire and the intolerance of uncertainty scale (IUS) before randomisation and divided into Group A (standard verbal and/or written hospital information) or Group B (standard information plus GEP film). Prior to results, they were interviewed about their GEP test knowledge and how the recurrence risk helps determine treatment options. After the results consultation, participants answered two further questionnaires. Participating clinicians completed IUS scales and reported their satisfaction with the results discussions. Results: 230/251 patients completed the study (Group A (n=106) and Group B (n=124)). The total knowledge score was higher in Group B (estimated between groups mean difference of 2.5 (95% CI:1.7 to 3.4) p<0.001). Most treatment decisions adhered to recommended risk of recurrence thresholds, although patients with higher trait anxiety were more likely to make less apparently rational decisions OR=0.93 (95%CI 0.88 to 0.97) p=0.002 (163/230; 70.8% received ET alone; 65/230; 28% ET plus chemotherapy, and two sought second opinions). Clinicians reported slightly longer consultations for Group A participants who tended to ask more difficult and unexpected questions. Conclusion: Patients who received standard verbal and written information plus film had increased knowledge about GEP tests compared with standard information alone. Trial registration number: ISRCTN28497350.