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

Peking Union Medical College Hospital0 sites108 target enrollmentMarch 7, 2022

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Peking Union Medical College Hospital
Enrollment: 108
Primary Endpoint: Change from baseline quality of life scores at 4 months
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 7, 2022

End Date

December 7, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline quality of life scores at 4 months

Time Frame: 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).