Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients: A Randomized Controlled Trial
Sponsor: Dena h. Al-Tameemi
Trial Details
| Condition | Breast Cancer, Breast Neoplasm, Chemotherapy-Related Toxicities, Medication Adherence, Quality of Life in Cancer Patients, Accuracy of AI App, Symptom Management |
| Intervention | AI-Based Mobile Application for Personalized Chemotherapy Support; Usual Care |
| Phase | NA |
| Status | Recruiting |
| Participants | 130 |
| Est. Completion | 1 July 2026 |
| Last Updated | 12 June 2026 |
Primary Outcome
Change in Symptom Burden and Chemotherapy-Related Toxicities (Arabic PRO-CTCAE); Medication Adherence Score (Arabic MMAS-8; Change in Patient Knowledge and Information Satisfaction (EORTC QLQ-INFO25); Change in General Quality of Life (EORTC QLQ-C30); Change in Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23)
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * 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. * Possession of a smartphone (Android or iOS) and functional digital literacy, defined as the ability to independently navigate mobile applications, read on-screen text in Arabic, and input daily health data. (for the intervention group). * Willingness to comply with study procedures and follow-up schedules. * Ability to communicate in Arabic, as the mobile application and chatbot will be developed in Arabic. Exclusion Criteria: * Patients with Stage IV (Metastatic) breast cancer. * Patients receiving concurrent hormonal therapy during the chemotherapy phase, to isolate chemotherapy-induced adverse events. Patients with cognitive impairment or severe psychiatric disorders that would preclude effective interaction with the mobile application or questionnaire completion. * 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. * Patients with severe comorbidities that could significantly impact their ability to participate or bias outcome measures.
Trial Sites
Countries
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