Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients

Официальное название

Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients: A Randomized Controlled Trial

Обзор

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.

Подробное описание

Despite advances in oncology care, breast cancer patients in Iraq face significant challenges regarding medication adherence and symptom management during the inter-cycle chemotherapy periods. This randomized controlled trial aims to bridge this gap by evaluating the efficacy, safety, and feasibility of a specialized, Arabic-language Artificial Intelligence (AI) mobile application.

Current standard care in the local setting often relies on episodic clinic visits, leaving patients without real-time support for side effects experienced at home. This study hypothesizes that a continuous, AI-driven digital intervention can reduce symptom burden and improve adherence to chemotherapy and supportive care medications (e.g., antiemetics) compared to standard care alone. The application utilizes Natural Language Processing (NLP) to provide conversational support tailored specifically to the cultural and linguistic context of Iraqi patients.

The intervention integrates a "Human-in-the-loop" safety model to ensure clinical accuracy. The AI algorithms are trained on clinical practice guidelines adapted for the local formulary.

Symptom Triage Logic: The app utilizes an algorithm based on the CTCAE grading system. Low-grade symptoms trigger self-care advice (e.g., hydration, dietary changes), while high-grade symptoms trigger immediate alerts to the patient to seek care and a notification to the study investigators.

Adherence Algorithms: Unlike static alarms, the notification system adapts to the specific chemotherapy cycle (e.g., AC or Taxane-based regimens) to remind patients of specific supportive medications required on specific days.

Control Group Specification (Standard of Care) Participants randomized to the control arm will receive the institutional standard of care. This includes routine oncologist consultations, standard written or verbal discharge instructions regarding chemotherapy side effects, and pharmacy dispensing counseling. They will not have access to the interactive AI features but will undergo the same schedule of outcome assessments to ensure rigorous comparison.

This study represents the first empirical effort to integrate AI-driven digital health tools into the public oncology sector in Iraq. It aims to validate whether automated, algorithmic triage is a feasible addition to the healthcare infrastructure in low-resource settings.

Вмешательства

• Поведенческое AI-Based Mobile Application for Personalized Chemotherapy Support
  The intervention is an Arabic-language mobile application powered by artificial intelligence (AI) designed to provide personalized chemotherapy support for women with breast cancer. The app assists participants by monitoring symptoms, sending medication adherence reminders, and offering educational content on managing side effects and improving treatment understanding. It uses a conversational interface based on natural language processing (NLP) to communicate with users. Participants are ask
• Другое Usual Care
  Standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.

Первичные конечные точки

• Change in Symptom Burden and Chemotherapy-Related Toxicities (Arabic PRO-CTCAE) [Срок оценки: Up to 12 weeks]
• Medication Adherence Score (Arabic MMAS-8 [Срок оценки: Baseline and at weeks 6,12.]
• Change in Patient Knowledge and Information Satisfaction (EORTC QLQ-INFO25) [Срок оценки: Baseline and at weeks 6,12.]
• Change in General Quality of Life (EORTC QLQ-C30) [Срок оценки: Baseline and at weeks 6,12.]
• Change in Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23) [Срок оценки: Baseline and at weeks 6,12.]

Вторичные конечные точки (4)

• Accuracy of AI-Generated Advice Compared with Oncologist Assessment [Срок оценки: Through study completion, an average of 12 weeks.]
• User Satisfaction and App Usability Score [Срок оценки: At 12 weeks (end of intervention)]
• App Usage Frequency [Срок оценки: Continuously during the 12-week intervention.]
• Identification of Technical, Ethical, and Implementation Barriers [Срок оценки: After 12 weeks of intervention use and upon study completion.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Ирак · 1 центр

• Oncology Teaching Hospital-Medical City- Baghdad — Baghdad

Публикации

• Batran RA, Tahoun S, Helmy L, Bahr A, Khalil A, Kamel M, Elsokary M. Breast Cancer in the Middle East and North Africa: Economic Burden, Market Trends, and Care Challenges. JCO Oncol Pract. 2026 May;22(5):769-779. doi: 10.1200/OP-25-00354. Epub 2025 Jul 16. PMID 40669034
• Anber ZNH, Saleh BOM, Al-Rawi SA. The cardiotoxicity effect of different chemotherapeutic regimens in Iraqi patients with breast cancer: A follow up study. Heliyon. 2019 Aug 1;5(8):e02194. doi: 10.1016/j.heliyon.2019.e02194. eCollection 2019 Aug. PMID 31406940
• Suhail M, Saulat F, Khurram H, Fatima F, Zenab A, Wasim M, Sadia NU, Afzaal F, Latif H, Nasrullah M. Knowledge, Attitude and Practice Related to Chemotherapy Among Cancer Patients. Inquiry. 2024 Jan-Dec;61:469580241246460. doi: 10.1177/00469580241246460. PMID 38616652
• Yelne S, Chaudhary M, Dod K, Sayyad A, Sharma R. Harnessing the Power of AI: A Comprehensive Review of Its Impact and Challenges in Nursing Science and Healthcare. Cureus. 2023 Nov 22;15(11):e49252. doi: 10.7759/cureus.49252. eCollection 2023 Nov. PMID 38143615
• Shaban M, Osman YM, Mohamed NA, Shaban MM. Empowering breast cancer clients through AI chatbots: transforming knowledge and attitudes for enhanced nursing care. BMC Nurs. 2025 Jul 29;24(1):994. doi: 10.1186/s12912-025-03585-w. PMID 40731340

Идентификаторы

NCT: NCT07273812 · RECAUBCP2192506C

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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