Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients: A Randomized Controlled Trial
Trial ID: NCT07273812
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-05
Completion date: 2026-10
Sponsor: Dena h. Al-Tameemi
Collaborators: Baghdad Medical City
Conditions: Breast Cancer; Breast Neoplasm; Chemotherapy-Related Toxicities; Medication Adherence; Quality of Life in Cancer Patients; Accuracy of AI App; Symptom Management
Interventions: AI-Based Mobile Application for Personalized Chemotherapy Support; Usual Care
Locations: Oncology Teaching Hospital-Medical City- Baghdad
Countries: Iraq
Enrollment: 130
Age range: 18 Years - None
Sex: FEMALE

Summary:
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:
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.

Outcomes:
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)