Artificial Intelligence-supported Mobile Application for Patients With Breast Cancer
NCT07826338
Summary
This randomized controlled clinical trial aims to evaluate the effects of an artificial intelligence-supported mobile application on symptom management, self-efficacy, and quality of life in breast cancer patients receiving chemotherapy. The study will be conducted between June 2026 and December 2026 at the Ege University Hospital Berna Türek Chemotherapy Center and the İzmir City Hospital Chemotherapy Center. Seventy breast cancer patients who will receive chemotherapy for the first time will be randomly assigned to either an intervention group using the mobile application or a control group receiving standard care. The study seeks to answer the following key questions: Does the artificial intelligence-supported mobile application improve symptom management? Does use of the application increase patients' self-efficacy? Does the application improve quality of life compared with standard care? Participants in the intervention group will use the mobile application during chemotherapy, report daily symptoms, and receive personalized symptom-management recommendations generated by an artificial intelligence system trained by the research team. Participants in both groups will complete symptom, self-efficacy, and quality-of-life assessments at baseline, after the first chemotherapy cycle (cycle length varies by chemotherapy protocol; all cycles are defined according to each patient's prescribed treatment regimen), and after the fourth cycle. The control group will receive standard care and complete the same assessments through face-to-face visits. This study is designed to assess the effectiveness of artificial intelligence-supported mobile health interventions in breast cancer care and their potential to improve symptom management, self-efficacy, and quality of life.
Eligibility
Inclusion Criteria: * Female patients aged 18 years and older. * Diagnosed with breast cancer. * Patients with Stage 0, I, II, or III breast cancer. * Receiving chemotherapy for the first time. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * In a stable physical and psychological condition that does not interfere with participation in the study. * Able to read and write in Turkish. * Own a smartphone and have sufficient technological skills to use the mobile application. * Willing to participate in the study and able to provide written informed consent. Exclusion Criteria: * Patients diagnosed with a primary cancer other than breast cancer. * Patients with severe comorbid diseases. * Patients receiving concurrent radiotherapy. * Patients diagnosed with inflammatory breast cancer. * Patients using luteinizing hormone-releasing hormone (LHRH) analogs. * Patients with severe cognitive impairment or psychiatric disorders. * Patients who do not have access to a mobile device or internet connection. * Patients who do not have the skills necessary to use the mobile application.
Conditions3
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NCT07826338