Breast Cancer
Conditions
Keywords
Application, Adverse Event, Quality of Life, Chemotherapy
Brief 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.
Interventions
OTHERuse 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.
OTHERconventional 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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. pathological diagnosis of invasive breast cancer 2. breast surgery within the past 2-8 weeks 3. adult female 4. must be able to use mobile phones 5. speak and write Chinese fluently to sign the informed consent
Exclusion criteria
1. severe comorbidity that interferes with outcome evaluation 2. insufficient Chinese language skills 3. inability to use mobile phones 4. cognitive disability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline quality of life scores at 4 months | 1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of 12 common adverse events | 4 months after the first cycle (each cycle is 21 days) | The incidence and severity of 12 common adverse events will be measured with the WHO-toxicity scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Login times | Documented automatically by the application every two weeks | Login times to the application during chemotherapy |
| Average time spent on the application | Documented automatically by the application every two weeks | Average time spent on the application each time |
| Questions addressed on the Q&A platform | Documented automatically by the application every two weeks | Questions addressed on the Q&A platform |
Contacts
Primary ContactYan Li, Doctor
Outcome results
None listed