Evaluating the effect of a mobile-based symptom monitoring system for improving physical function in patients with cancer during chemotherapy: study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Symptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life and increased mortality. Thus, timely symptom identification is critical for improving cancer prognosis and survival. Recently, remote symptom monitoring system using digital technology has demonstrated its effects on symptom control or survival. However, few studies examined whether remote monitoring would contribute to retaining physical function among patients with cancer. Therefore, this study aimed to evaluate the effectiveness of mobile-based symptom monitoring in improving physical function among patients with cancer under chemotherapy. METHODS AND ANALYSIS: This study is a multicentre, open-label, parallel-group, randomised controlled trial. We will recruit 372 patients at three tertiary hospitals located in Seoul, South Korea. Study participants will be randomly assigned to either an intervention group receiving the ePRO-CTCAE app and a control group receiving routine clinical practice only. The primary outcome is changes in physical function from commencement to completion of planned chemotherapy. A linear mixed model will be performed under the intention-to-treat principle. The secondary outcomes include physical activity level; changes in pain interference; changes in depressive symptom; unplanned clinical visits; additional medical expenditure for symptom management; completion rate of planned chemotherapy; changes in symptom burden and health-related quality of life; and 1-year overall mortality. ETHICS AND DISSEMINATION: The study has been approved by the institutional review board and ethics committee at the three university hospitals involved in this trial. Written informed consent will be obtained from all the participants. The results of the trial will be submitted for publication in peer-reviewed academic journals and disseminated through relevant literatures. TRIAL REGISTRATION NUMBER: KCT0007220.

Mediating effect of negative perceived stress on the relationship between premenstrual syndrome and emotional eating.

BACKGROUND/OBJECTIVES: Emotional eating is one of the eating behaviors in which negative emotions affect eating. During the luteal phase, premenstrual syndrome (PMS) and its associated psychological and physical symptoms can appear in some women, and a few of them suffer from premenstrual dysphoric disorder (PMDD), a severe form of PMS. Some women diagnosed with PMS/PMDD experience emotional eating during the luteal phase, which may be a coping mechanism for psychological stress. This study aimed to investigate how PMS/PMDD and negatively perceived stress are related to emotional eating. SUBJECTS/METHODS: A total of 409 women aged 20 to 39 yrs with a body mass index (BMI) ranging from 18.5 to 29.9 kg/m2 participated in this study. Participants who responded to all the questions of the Shortened Premenstrual Assessment Form, Negative Perceived Stress Scale, and Emotional Eater Questionnaire were divided into a PMDD and a non-PMDD group according to the cut-off value for PMDD diagnosis. Independent t-tests and mediation analyses were performed to compare the 2 groups. RESULTS: No significant differences between the 2 groups were found in terms of BMI; however, the average values for emotional eating, PMS, and negative perceived stress of the PMDD group were significantly higher than those of the non-PMDD group. Only negative perceived stress had a significant effect on emotional eating in the non-PMDD group. In the PMDD group, PMS was statistically significant for both negative perceived stress and emotional eating mediated by negative perceived stress. Consequently, it appeared to have a partial or complete mediation depending on the independent variable for the PMDD group. CONCLUSIONS: This study highlights the importance of managing negative perceived stress to control emotional eating in PMS/PMDD for improved women's health.