Breast Cancer Clinical Trial
Official title:
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 108 |
Est. completion date | December 7, 2022 |
Est. primary completion date | October 7, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
Cheng JX, Liu BL, Zhang X, Zhang YQ, Lin W, Wang R, Zhang YQ, Zhang HY, Xie L, Huo JL. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011 Apr 22;11:56. doi: 10.1186/1471-2288-11-56. — View Citation
Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Login times | Login times to the application during chemotherapy | Documented automatically by the application every two weeks | |
Other | Average time spent on the application | Average time spent on the application each time | Documented automatically by the application every two weeks | |
Other | Questions addressed on the Q&A platform | Questions addressed on the Q&A platform | Documented automatically by the application every two weeks | |
Primary | Change from baseline quality of life scores at 4 months | 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). | 1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days) | |
Secondary | Incidence and severity of 12 common adverse events | The incidence and severity of 12 common adverse events will be measured with the WHO-toxicity scale. | 4 months after the first cycle (each cycle is 21 days) |
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