Data from 441 patients contributed to a total of 84,212 individually reported symptoms during a mean period of 7.4 months. data were obtained from an early breast cancer trial (version 1 of the app, n=86) and an ongoing study including patients with advanced disease (version 2 of the app, n=106). In both app versions, patients and doctors were allowed to share the information from data entries during consultations. Version 2 of the app, however, randomly selected symptoms that required a detailed and shared regular patient-doctor review in order to focus on the collection and appropriate interpretation regarding awareness and guidance for severity grading. The numbers and types of symptom entries, satisfaction with both app versions, and patients perceived effects during consultations were included for analysis. Results Symptom severity grading was performed according to the Common Terminology Criteria for Adverse Events (CTCAE) using a horizontal slider and was indicated in descriptive terminology in both apps, while a graphical display facilitated Mouse monoclonal to HK2 the illustration of symptom history charts. In total, 192 patients electronically reported 11,437 data entries on well-being and 33,380 data entries on individual symptoms. Overall, 628 (of 872 intended) requested patient-doctor symptom reviews were performed in version 2 of the app. Both the amount of data entries per patient and day for well-being (version 1 vs version 2: 0.3 vs 1.0; values .05 were considered statistically significant. There was no adjustment for multiple testing. All statistical analyses were performed using R version 4.0.0 (R Foundation for Statistical Computing). The research complies with the guidelines for human studies and was conducted ethically in accordance with the World Medical Association Declaration of Helsinki. We state that all participants provided written informed consent to publish their data. Both study protocols (“type”:”clinical-trial”,”attrs”:”text”:”NCT02004496″,”term_id”:”NCT02004496″NCT02004496 and “type”:”clinical-trial”,”attrs”:”text”:”NCT03578731″,”term_id”:”NCT03578731″NCT03578731) were approved by the local ethics committee on human research. Results Baseline Characteristics Between December 2013 and July 2015, 86 breast cancer patients using version 1 of the app completed all study visits, while for version 2 of the app, data from a subset of 106 patients were available for analysis upon recruitment from November 2018 to October 2019. For descriptive comparison, baseline characteristics as distributed between both patient groups are displayed in Table 1. The mean age of the patients using version 1 of the app was 52 years, and that of the AZ 23 patients using version 2 of the app was 56 years (Table 1). All 86 patients using version 1 of the app were treated for early stage disease, and two-thirds (n=54, 63%) of these patients were treated in an adjuvant setting. In contrast, about half (n=56, 53%) of the patients using version 2 of the app received treatment for advanced disease with noncurative intention. In patients using version 1 of the app, a total of seven distinct chemotherapeutic agents in six different chemotherapy regimens were administered (Figure 2), whereas a much greater variety of 16 distinct antitumoral agents, including AZ 23 antihormones, CDK4/6 inhibitors, and immunotherapies, were applied in patients using version 2 of the app. During the ePRO reporting period, the most frequent chemotherapy regimens applied in early stage breast cancer were epirubicin/cyclophosphamide (n=32), paclitaxel/ trastuzumab (n=19), and paclitaxel/carboplatin (n=12). In contrast, for users of version 2 of the app, the most commonly used therapeutic regimens were antihormones CDK4/6 inhibitors (n=25), carbo-docetaxel-Herceptin/Perjeta (n=13), docetaxel-endoxan (n=13), and checkpoint inhibitors (n=11) (Figure 2). Owing to more advanced disease stages and neoadjuvant regimens, CDK4/6 inhibitors and anti-HER2 antibodies were among the most applied drugs in the patient cohorts. Table 1 Patient demographics. value Version 1 (n=86)Version 2 (n=106)value Version 1 (n=86)Version 2 (n=67) /thead I find the app helpful62 (72%)61 (91%).003The app is easy to useN/Aa66 (99%)N/AaThe app helps me deal with the symptoms of my illness53 (62%)51 (76%).057The app AZ 23 has had a positive effect on doctor visits69 (80%)54 (81%).96My records were taken into account by the doctor during consultations81 (94%)60 (90%).29My symptoms are taken seriously by the doctor84 (98%)65 (97%)1.0I believe that my personal data will be treated confidentially84 (98%)67 (100%).50I would recommend the app to other patients84 (98%)65 (97%)1.0 Open in a separate window.