Role of pharmacists in providing information on cancer genome medicine and patient decision making：open-label randomized controlled study

Background Cancer genome medicine based on genetic mutations is developing globally, and comprehensive genome profiling (CGP) are now routinely performed in Japan. Patient expectations are high for new treatment modalities based on genetic testing, but these are mostly unknown in Japan. The role of pharmacists in cancer genome medicine has not yet been established, but they can be a potential source of reliable information on cancer genome medicine, thus improving the health literacy of patients and supporting their decision making. Methods This was an open-label randomized controlled study. Subjects were randomly assigned 1:1 to the intervention and non-intervention groups, with treatment objective (preoperative and postoperative/advanced recurrence) as a stratification factor. In the non-intervention group, the pharmacist provided explanations about the drugs as done in usual care. In addition, the intervention group was provided with information on CGP. The primary endpoint was the impact of the pharmacist’s intervention on the patient’s decision making, measured by the Decisional Conflict Scale (DCS). As a secondary endpoint, factors influencing patient’s decision making were also analyzed. Results The analysis included responses from 180 patients. The pharmacist interview lasted 19.9 ± 6.9 and 10.4 ± 4.3 minutes for the intervention and non-intervention groups, respectively. The percentage of patients whose DCS scores decreased before and after the pharmacist interview was not significant between the intervention versus non-intervention groups (49.4% vs. 41.9%; p = 0.313, test of proportions). However, the DCS score of the intervention and non-intervention groups increased by 1.98 ± 16.5 and 3.61 ± 17.3, respectively. Both groups exhibited an increase in decisional conflict about receiving treatment, including CGP, but the change was significantly smaller in the intervention group (p = 0.026, unpaired t-test). Factors that influenced patient’s decision making through pharmacist intervention included age, chemotherapy being the primary treatment and having no history of nonsurgical treatment, such as chemotherapy, radiofrequency ablation, transcatheter arterial chemoembolization, and microwave ablation. Conclusions Increased conflicts is reduced when pharmacists provide information about CGP to patients undergoing cancer chemotherapy. This can help patients make informed decisions about their treatment choices.