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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Other: use of a smartphone app for adverse event management; Other: conventional adverse event management

• Registration Number: NCT05258461
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Study Start: 2022-03-07
• Primary Completion: 2022-10-07
• Study Completion: 2022-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intervention group	conventional adverse event management	The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.
The intervention group	use of a smartphone app for adverse event management	The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.
The control group	conventional adverse event management	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.