A randomized trial of the impact of symptom monitoring using an electronic patient-reported outcome app on health-related quality of life in postmenopausal breast cancer patients receiving adjuvant endocrine therapy.

BACKGROUND: Electronic patient-reported outcomes (ePRO) monitoring is a useful communication tool for cancer patients and healthcare providers. In this study, we examined the impact of symptom monitoring using an ePRO app on quality of life (QoL) in postmenopausal breast cancer patients receiving adjuvant endocrine therapy. METHODS: The free app "Welby My Carte ONC" was used in the study. Patients with breast cancer starting adjuvant endocrine therapy were randomly assigned in a 1:1 ratio to ePRO monitoring (ONC) and control groups. The ONC group reported five symptoms extracted from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) (insomnia, joint pain, headache, anxiety, and hot flashes) weekly for 3 months through the app. Reported symptoms were shared with medical personnel. When serious symptoms were reported, these personnel ascertained the patient's health status and provided advice over the phone. The primary endpoint was QoL measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 3 months from enrollment. Differences between groups were tested using analysis of covariance. RESULTS: The study included 125 subjects with mean age of 64 years in the ONC group (n = 61) and 63 years in the control group (n = 64). In the ONC group, the response rate to PRO-CTCAE was about 70% or higher until week 10. The item missing rate was 0. The ONC group reported more symptoms related to joint pain and insomnia. The difference in FACT-B total score between the groups was - 1.55 (95% confidence interval: - 5.91, 2.81), indicating no significant difference. CONCLUSIONS: Symptom monitoring using ePRO early after initiation of adjuvant endocrine therapy after surgery did not improve QoL of breast cancer patients.

Application of Personal Health Record in Enhancing the Quality of Life in Patients With Breast Cancer Who Received Adjuvant Hormonal Therapy.

Objective: Recently, personal health records (PHR) have become a communication tool between patients and medical professionals. PHR applications (PHR app) can be installed on smartphones to record patient-reported outcomes (PROs). This study prospectively examined whether patients with breast cancer could record PROs, including subjective and objective symptoms, on PHR app. Materials and Methods: Patients who received adjuvant hormonal therapy were enrolled. The patients were asked to collect PROs related to physical conditions, symptoms, and medications on their PHR app from the beginning of therapy for one month. Quality of life (QoL) was evaluated before treatment initiation and one month after. Patients completed a questionnaire of their opinions concerning the PHR app after use. Results: Fourteen patients were enrolled between October and December 2020. All patients could use the PHR app during the study period without any negative effects on QoL. Eleven (79%) patients fully recorded their PROs on the app. Typical side effects induced by hormonal therapy to reduce the QoL were observed (hot flash in two patients, 14.3%). The questionnaire revealed that approximately 70% wanted to use the PHR app in the future to communicate with medical staff and to report adverse events. Specifically, 90% of patients who experienced difficulty communicating with medical staff wanted to use the PHR app. Some patients wanted to utilize the PHR app to set reminders to take medications. Conclusion: The PHR app can be applied as a communication tool between patients taking adjuvant hormonal therapy and medical professionals.