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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: use of a smartphone app for adverse event management; Other: conventional adverse event management

Study type: Interventional

Funder types: Other

Identifiers

NCT05258461

Smart

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

The intervention group

Experimental group

Description:

The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.

Treatment:

Other: conventional adverse event management

Other: use of a smartphone app for adverse event management

The control group

Active Comparator group

Description:

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.

Treatment:

Other: conventional adverse event management