Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients
NCT ID: NCT07273812
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
130 participants
INTERVENTIONAL
2026-02-28
2026-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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AI-Based Mobile Application Plus Usual Care
Participants in this group will receive the AI-based mobile application in addition to usual oncology care.
The Arabic-language mobile app uses artificial intelligence (AI) to provide personalized chemotherapy support, including symptom monitoring, medication adherence reminders, and educational guidance.
Participants will use the app daily for 12 weeks during their chemotherapy cycles.
All AI-generated advice is reviewed by oncologists and pharmacists to ensure clinical safety.
They will also receive standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.
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 asked to use the app daily for 12 weeks while receiving chemotherapy.
A human-in-the-loop system ensures oncologists and pharmacists review AI-generated advice for accuracy and safety.
Usual Care
Standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.
Usual Care Only
Participants in this group will receive standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.
They will not have access to the AI-based mobile application.
Usual Care
Standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.
Interventions
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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 asked to use the app daily for 12 weeks while receiving chemotherapy.
A human-in-the-loop system ensures oncologists and pharmacists review AI-generated advice for accuracy and safety.
Usual Care
Standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Baghdad Medical City
OTHER
Dena h. Al-Tameemi
OTHER
Responsible Party
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Dena h. Al-Tameemi
Principal Investigator, University of Baghdad
Principal Investigators
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Samer Imad Mohammed, Assistant Prof
Role: PRINCIPAL_INVESTIGATOR
University of Baghdad-College of Pharmacy
Locations
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Oncology Teaching Hospital-Medical City- Baghdad
Baghdad, , Iraq
Countries
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Central Contacts
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Facility Contacts
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References
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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. 2025 Jul 16:OP2500354. doi: 10.1200/OP-25-00354. Online ahead of print.
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.
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.
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.
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.
Related Links
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College of Pharmacy, University of Baghdad - Academic sponsor
Oncology Teaching Hospital, Baghdad - Study location
National Cancer Institute - Breast Cancer Overview
National Cancer Comprehensive Network- Treatment Guidelines
Other Identifiers
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RECAUBCP2192506C
Identifier Type: -
Identifier Source: org_study_id
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