Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients
AI-ChemoApp
1 other identifier
interventional
130
1 country
1
Brief 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?
- 5.Use the mobile app daily for 12 weeks while receiving chemotherapy.
- 6.Complete short questionnaires about symptoms, medication use, and quality of life at the start and end of the study.
- 7.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started May 2026
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
December 10, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
April 21, 2026
November 1, 2025
2 months
November 17, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in Symptom Burden and Chemotherapy-Related Toxicities (Arabic PRO-CTCAE)
Symptom burden and treatment-related toxicities will be assessed using the validated Arabic version of the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). Participants will report frequency, severity, and interference of common chemotherapy-related symptoms such as fatigue, nausea, vomiting, pain, and neuropathy. Mean score changes between baseline and 12 weeks will be compared between the AI app group and the usual care group to evaluate whether the intervention lowers symptom burden and improves self-management.Data will be collected at Baseline and weekly thereafter.
Up to 12 weeks
Medication Adherence Score (Arabic MMAS-8
Medication adherence will be measured using the 8-item Morisky Medication Adherence Scale (MMAS-8) in its validated Arabic version. Participants' self-reported responses generate a score from 0-8, with higher scores indicating better adherence. The mean change in adherence scores from baseline to 12 weeks will be compared between groups to determine the app's effectiveness in promoting medication adherence during chemotherapy.
Baseline and at weeks 6,12.
Change in Patient Knowledge and Information Satisfaction (EORTC QLQ-INFO25)
The Arabic version of EORTC QLQ-INFO25 questionnaire will assess participants' perception of the adequacy, clarity, and usefulness of information provided about their disease, treatment, and care. The total score ranges from 0 to 100, with higher scores reflecting greater satisfaction with information. The AI-based mobile app is expected to increase knowledge and satisfaction through personalized, accessible education.
Baseline and at weeks 6,12.
Change in General Quality of Life (EORTC QLQ-C30)
Quality of life (QoL) will be measured using the validated Arabic version of the EORTC QLQ-C30. The EORTC QLQ-C30 is a 30-item questionnaire used to assess the quality of life of cancer patients. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), and a global health status/QoL scale. Raw scores are transformed to a linear scale ranging from 0 to 100. Functional Scales \& Global Health Status: Higher scores represent a higher/better level of functioning and quality of life. Symptom Scales: Higher scores represent a higher/worse level of symptomatology.
Baseline and at weeks 6,12.
Change in Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23)
The Arabic version of EORTC QLQ-BR23 will be used to assess the change in Breast Cancer-Specific Quality of Life.The EORTC QLQ-BR23 is a supplementary module specifically for breast cancer patients. It consists of 23 items covering functional scales (body image, sexual functioning, future perspective) and symptom scales (side effects of systemic therapy, breast symptoms, arm symptoms, hair loss). Raw scores are transformed to a linear scale ranging from 0 to 100. Functional Scales: Higher scores represent better functioning. Symptom Scales: Higher scores represent worse symptoms.
Baseline and at weeks 6,12.
Secondary Outcomes (4)
Accuracy of AI-Generated Advice Compared with Oncologist Assessment
Through study completion, an average of 12 weeks.
User Satisfaction and App Usability Score
At 12 weeks (end of intervention)
App Usage Frequency
Continuously during the 12-week intervention.
Identification of Technical, Ethical, and Implementation Barriers
After 12 weeks of intervention use and upon study completion.
Study Arms (2)
AI-Based Mobile Application Plus Usual Care
EXPERIMENTALParticipants 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.
Usual Care Only
ACTIVE COMPARATORParticipants 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.
Interventions
Standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dena h. Al-Tameemilead
- Baghdad Medical Citycollaborator
Study Sites (1)
Oncology Teaching Hospital-Medical City- Baghdad
Baghdad, Iraq
Related Publications (5)
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.
PMID: 40669034BACKGROUNDAnber 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: 31406940BACKGROUNDSuhail 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: 38616652BACKGROUNDYelne 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: 38143615BACKGROUNDShaban 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: 40731340BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samer Imad Mohammed, Assistant Prof
University of Baghdad-College of Pharmacy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, University of Baghdad
Study Record Dates
First Submitted
November 17, 2025
First Posted
December 10, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
April 21, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Deidentified individual participant data and related documents will be available beginning 6 months after publication of the main study results and for up to 3 years thereafter. Requests beyond this period will be considered on a case-by-case basis depending on data availability and ethical approval.
- Access Criteria
- Access to the deidentified data will be granted to qualified investigators for non-commercial academic research. Requests must include a clear research proposal and data-use agreement ensuring data protection. Data will be shared electronically through secure university-approved transfer methods after approval by the principal investigator and the Research Ethics Committee, College of Pharmacy, University of Baghdad.
Deidentified individual participant data (IPD) that underlie the results reported in published articles will be made available to qualified academic researchers upon reasonable request. Data sharing will occur after publication of the main results and subject to approval by the Research Ethics Committee, College of Pharmacy, University of Baghdad. Data will include coded variables without any identifiers to ensure participant confidentiality.