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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Iraq
Oncology Teaching Hospital-Medical City- Baghdad
RECRUITING
Baghdad
Contact Information
Primary
Dena A. Al-Tameemi, MSc.
dina.abbas2400p@copharm.uobaghdad.edu.iq
+9647901572647
Backup
Samer Imad Mohammed, PhD
Samer.jameel@copharm.uobag
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2026-11-06
Participants
Target number of participants: 130
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Baghdad Medical City
Leads: Dena h. Al-Tameemi

This content was sourced from clinicaltrials.gov

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