An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy

An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy

An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial

The aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. The investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (QoL) scores and reduce adverse events.

The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.

The control group will receive conventional adverse event management during chemotherapy. Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.

At their enrollment, patients will receive detailed introduction and adequate assistance on the use of the smartphone app. The smartphone app will offer proper advice for adverse event management based on calculated results by artificial intelligence on the innovative app, which was developed by YL et al. It was specifically intended for risk prediction, early prevention, as well as management of symptoms and concerns during adjuvant chemotherapy in the treatment of breast cancer. The app consisted of 4 modules: (1) Module 1: clinical data collection. (2) Module 2: risk evaluation for 12 common adverse events during breast cancer chemotherapy. (3) Module 3: personalized prophylaxis based on predicted risks of adverse events. (4) Module 4: Q&A platform.

Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience. For example, colony-stimulating factors and antibiotics may be used for febrile neutropenia, loperamide (or diphenoxylate plus atropine) as prophylaxis for diarrhea, together with eating low-lactose and low-fat frequent small meals. 5-hydroxytryptamine 3 receptor antagonist, neurokinin 1 receptor antagonist, and/or dexamethasone would be prescribed for patients at high risks of vomiting.

Quality of life scores will be assessed using the simplified Chinese version of the Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3).

Inclusion Criteria: pathological diagnosis of invasive breast cancer breast surgery within the past 2-8 weeks adult female must be able to use mobile phones speak and write Chinese fluently to sign the informed consent Exclusion Criteria: severe comorbidity that interferes with outcome evaluation insufficient Chinese language skills inability to use mobile phones cognitive disability to give informed consent

Department of Breast Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

Cheng JX, Liu BL, Zhang X, Zhang YQ, Lin W, Wang R, Zhang YQ, Zhang HY, Xie L, Huo JL. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011 Apr 22;11:56. doi: 10.1186/1471-2288-11-56.

Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24.

Guidelines of Chinese Society of Clinical Oncology (CSCO) on Diagnosis and Treatment of Breast Cancer (2020 version)