Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients (NCT07273812) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients
Iraq130 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Symptom Burden and Chemotherapy-Related Toxicities (Arabic PRO-CTCAE)
Timeframe: Up to 12 weeks
2
Medication Adherence Score (Arabic MMAS-8
Timeframe: Baseline and at weeks 6,12.
3
Change in Patient Knowledge and Information Satisfaction (EORTC QLQ-INFO25)
Timeframe: Baseline and at weeks 6,12.
4
Change in General Quality of Life (EORTC QLQ-C30)
Timeframe: Baseline and at weeks 6,12.
5
Change in Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23)