Satoko Handa1, Hiromi Okuyama2, Hitomi Yamamoto3, Seigo Nakamura2, Yasuhisa Kato3. 1. Division of Drug Information Analytics, Department of Clinical Pharmacy, Showa University School of Pharmacy, Tokyo, Japan. Electronic address: shanda@pharm.showa-u.ac.jp. 2. Department of Breast Surgery, Showa University School of Medicine, Tokyo, Japan. 3. Division of Drug Information Analytics, Department of Clinical Pharmacy, Showa University School of Pharmacy, Tokyo, Japan.
Abstract
BACKGROUND:Outpatients undergoing cancer chemotherapy experience anxiety related to adverse drug reactions that they can experience at home. We developed a breast cancer patient support system (BPSS) application (app). The BPSS app chronologically and quantitatively records patients' subjective and objective symptoms during breast cancer chemotherapy, with the goal of providing supportive management for adverse drug reactions. The present study examined whether the BPSS app is an effective tool for supporting patients undergoing chemotherapy. PATIENTS AND METHODS: A total of 102 patients undergoing chemotherapy at the Showa University Hospital (Tokyo, Japan) were enrolled in the present order- and age-controlled clinical trial and randomized into BPSS or no-BPSS app groups. The patients underwent 4 courses of chemotherapy. The primary outcome was the change in the hospital anxiety and depression scale score, which was assessed directly before and after the 4 courses of chemotherapy. Other outcomes included health literacy (measured using the 14-item health literacy scale (HLS-14), side effects, and app adherence. RESULTS: Of the 102 patients, 95 completed the present study. No significant improvement was seen in anxiety, depression, or health literacy at the end of treatment between the BPSS and no-BPSS app groups. Overall, 1868 side effects were reported. When the patients' records were compared with the medical staff records, the analysis revealed that the medical staff had 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.
RCT Entities:
BACKGROUND: Outpatients undergoing cancer chemotherapy experience anxiety related to adverse drug reactions that they can experience at home. We developed a breast cancerpatient support system (BPSS) application (app). The BPSS app chronologically and quantitatively records patients' subjective and objective symptoms during breast cancer chemotherapy, with the goal of providing supportive management for adverse drug reactions. The present study examined whether the BPSS app is an effective tool for supporting patients undergoing chemotherapy. PATIENTS AND METHODS: A total of 102 patients undergoing chemotherapy at the Showa University Hospital (Tokyo, Japan) were enrolled in the present order- and age-controlled clinical trial and randomized into BPSS or no-BPSS app groups. The patients underwent 4 courses of chemotherapy. The primary outcome was the change in the hospital anxiety and depression scale score, which was assessed directly before and after the 4 courses of chemotherapy. Other outcomes included health literacy (measured using the 14-item health literacy scale (HLS-14), side effects, and app adherence. RESULTS: Of the 102 patients, 95 completed the present study. No significant improvement was seen in anxiety, depression, or health literacy at the end of treatment between the BPSS and no-BPSS app groups. Overall, 1868 side effects were reported. When the patients' records were compared with the medical staff records, the analysis revealed that the medical staff had 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.
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