Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Anti-Infective Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Anti-Arrhythmia Agents

Adjuvants, Anesthesia

Respiratory System Agents

Analgesics

Central Nervous System Depressants

Anti-Bacterial Agents

Dexamethasone

Atropine

Loperamide

Dexamethasone acetate

Antibiotics, Antitubercular

Neurokinin-1 Receptor Antagonists

Serotonin

Substance P

Neurokinin A

Diphenoxylate

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.

use of a smartphone app for 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.

conventional adverse event management

Yan Li, Doctor

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.

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 data will not become available to public.

Login times to the application during chemotherapy

Average time spent on the application each time

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).

The incidence and severity of 12 common adverse events will be measured with the WHO-toxicity scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy	NCT05258461	Breast Cancer	use of a smartp... conventional ad...	18 Years -	Peking Union Medical College Hospital
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy	NCT05258461	Breast Cancer	use of a smartp... conventional ad...	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for conventional adverse event management