NCT05258461

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	use of a smartphone app for adverse event management	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.
OTHER	conventional adverse event management	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.

Timeline

• Start date: 2022-03-07
• Primary completion: 2022-10-07
• Completion: 2022-12-07
• First posted: 2022-02-28
• Last updated: 2022-02-28