About this trial
The goal of this clinical trial is to learn if an Arabic-language mobile application that uses artificial intelligence (AI) can help women with breast cancer during chemotherapy. The app is designed to give personalized support by reminding participants about their medications, teaching them how to manage treatment side effects, and alerting their healthcare team about serious symptoms.
The main questions this study aims to answer are:
1. Does the AI-based mobile app provide accurate and safe recommendations for the patients? 2. Does using the AI-based mobile app help lower treatment-related symptoms and side effects compared to usual care? 3. Does the app help participants take their medications more regularly? 4. Does it increase participants' understanding and satisfaction with the information they receive about their treatment?
Researchers will compare two groups:
Group 1: Participants who use the AI-based mobile app plus usual oncology care. Group 2: Participants who receive usual care only.
Participants will:
1. Use the mobile app daily for 12 weeks while receiving chemotherapy. 2. Complete short questionnaires about symptoms, medication use, and quality of life at the start and end of the study. 3. Report any problems or feedback about using the app. The AI app is for support and education only. It does not make treatment decisions. All information from the app will be reviewed by oncologists and pharmacists to ensure participant safety.
Eligibility criteria
Qualifiers
Confirmed diagnosis of breast cancer stages I, II, or III.
Patients must be currently scheduled to initiate their first-ever cycle of chemotherapy.
Age 18 years or older.
Ability to understand and provide informed consent.
Disqualifiers
Patients with Stage IV (Metastatic) breast cancer.
Patients receiving concurrent hormonal therapy during the chemotherapy phase, to isolate chemotherapy-induced adverse events.
Patients receiving palliative care where symptom management is the sole focus and active chemotherapy is not being administered with curative or life prolonging intent.
Patients participating in other interventional clinical trials that might confound the outcomes of this study.
Trial design
Treatments tested in this trial
- AI-Based Mobile Application for Personalized Chemotherapy Support
- Usual Care
Treatment groups
Sponsors and collaborators
Dena h. Al-Tameemi
Lead sponsor
University of Baghdad
Sponsor institution
Baghdad Medical City
Collaborator