Effectiveness of a smartphone application as a support tool for patients undergoing breast cancer chemotherapy: A randomized controlled trial

Abstract Background Outpatients undergoing cancer chemotherapy experience anxiety related to adverse drug reactions that they might experience at home. We developed a Breast Cancer Patient Support System (BPSS) application, which chronologically and quantitatively records patients’ subjective and objective symptoms during breast cancer chemotherapy, with the goal of providing supportive management of adverse drug reactions. This study examined whether the BPSS app was an effective tool for supporting patients undergoing chemotherapy. Patients and Methods One hundred two patients undergoing chemotherapy at the Showa University Hospital in Tokyo, Japan, were enrolled in the order- and age-controlled clinical trial and randomized into the BPSS or no-BPSS app groups. The patients underwent 4 courses of chemotherapy. The primary outcome was the change in hospital anxiety and depression scale (HADS) score, which was assessed directly before and after 4 courses of chemotherapy. Other outcomes included health literacy (measured with the HLS-14), side effects, and app adherence. Results Ninety-five patients completed the study. There was no significant improvement in anxiety, depression, or health literacy at the end of treatment between the BPSS and the no-BPSS app groups. Overall, 1,868 side effects were reported. When patients’ records were compared with medical staff records, the analysis revealed that medical staff underestimated some Grade 3 symptoms. Conclusion The BPSS app is a feasible tool for patients with breast cancer and might be useful as a support tool for information sharing between patients and medical staff in an effort to optimize chemotherapy and deliver suitable patient care and support.