Clinical trial · Interventional
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial
NCT05258461CI-TRIAL-00056774unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional adverse event management | Other | — | UNRESOLVED |
| use of a smartphone app for adverse event management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The intervention group
- description
- The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.
- interventionNames
- Other: use of a smartphone app for adverse event management
- Other: conventional adverse event management
- type
- ACTIVE_COMPARATOR
- label
- The control 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.
- interventionNames
- Other: conventional adverse event management
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDCheng 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. PMID 21513533
- BACKGROUNDWan 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. PMID 18653703