An interventional study of AI-Supported Mobile Application in Breast Cancer and Chemotherapy Side Effects, sponsored by Ege University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Ege University · Not applicable, Interventional, and Supportive care
This randomized controlled clinical trial aims to evaluate the effects of an artificial intelligence-supported mobile application on symptom management, self-efficacy, and quality of life in breast cancer patients receiving chemotherapy. The study will be conducted between June 2026 and December 2026 at the Ege University Hospital Berna Türek Chemotherapy Center and the İzmir City Hospital Chemotherapy Center. Seventy breast cancer patients who will receive chemotherapy for the first time will be randomly assigned to either an intervention group using the mobile application or a control group receiving standard care. The study seeks to answer the following key questions: Does the artificial intelligence-supported mobile application improve symptom management? Does use of the application increase patients' self-efficacy? Does the application improve quality of life compared with standard care? Participants in the intervention group will use the mobile application during chemotherapy, report daily symptoms, and receive personalized symptom-management recommendations generated by an artificial intelligence system trained by the research team. Participants in both groups will complete symptom, self-efficacy, and quality-of-life assessments at baseline, after the first chemotherapy cycle (cycle length varies by chemotherapy protocol; all cycles are defined according to each patient's prescribed treatment regimen), and after the fourth cycle. The control group will receive standard care and complete the same assessments through face-to-face visits. This study is designed to assess the effectiveness of artificial intelligence-supported mobile health interventions in breast cancer care and their potential to improve symptom management, self-efficacy, and quality of life.
Breast cancer is the most commonly diagnosed cancer worldwide and remains the leading cause of cancer-related mortality among women. Despite advances in diagnosis and treatment, patients undergoing chemotherapy frequently experience a wide range of physical and psychological symptoms, including fatigue, nausea, vomiting, pain, sleep disturbances, anxiety, depression, and impaired body image. These symptoms may negatively affect treatment adherence, self-management abilities, and health-related quality of life. Inadequately managed symptoms can also lead to treatment delays, dose reductions, emergency department visits, and hospitalizations. Effective symptom management is therefore a critical component of breast cancer care. Self-efficacy, defined as an individual's belief in their ability to successfully perform behaviors required to achieve desired outcomes, plays an important role in symptom management and adaptation to cancer treatment. Higher levels of self-efficacy have been associated with better symptom control, improved psychological well-being, enhanced patient-provider communication, and greater treatment adherence. In addition, maintaining and improving quality of life has become a major goal of contemporary cancer care. Mobile health technologies have emerged as promising tools for supporting symptom monitoring and self-management among cancer patients. Previous studies have demonstrated that electronic patient-reported outcome systems can facilitate timely symptom reporting, reduce symptom burden, improve quality of life, and potentially enhance survival outcomes. However, many existing mobile applications for breast cancer patients focus on limited aspects of care and do not comprehensively address the broad range of symptoms experienced during chemotherapy. Artificial intelligence has the potential to enhance mobile health interventions by providing personalized, real-time recommendations based on patient-reported data. Artificial intelligence-supported systems can analyze symptom reports, identify symptom severity, and deliver tailored guidance to support symptom self-management. Such personalized interventions may increase patient engagement, improve symptom control, strengthen self-efficacy, and ultimately enhance quality of life. The purpose of this randomized controlled trial is to evaluate the effects of an artificial intelligence-supported mobile application on symptom management, self-efficacy, and quality of life among breast cancer patients receiving chemotherapy for the first time. The study will be conducted between June 2026 and December 2026 at the Berna Türek Chemotherapy Center of Ege University Hospital and the Chemotherapy Center of İzmir City Hospital. A total of 70 breast cancer patients who meet the eligibility criteria will be enrolled and randomly assigned to either an intervention group (n=35) or a control group (n=35). Participants in the intervention group will download and use an artificial intelligence-supported mobile application on their Android smartphones on the first day of chemotherapy. Following chemotherapy initiation, participants will report their symptoms daily through the application. Based on symptom severity and patient-reported information, the artificial intelligence component of the application will provide individualized symptom-management recommendations developed according to evidence-based practices and supervised by the research team. Participants will also have access to educational content regarding breast cancer and its treatment through the application. Participants in the control group will receive standard care routinely provided by the treatment centers. Outcome assessments will be conducted at baseline (first chemotherapy day), at the end of the first chemotherapy cycle (cycle length varies by chemotherapy protocol; all cycles are defined according to each patient's prescribed treatment regimen), and at the end of the fourth chemotherapy cycle. Data will be collected using the patient identification form, the memorial symptom assessment scale (MSAS), the chemotherapy symptom management self-efficacy scale for breast cancer patients, the european organisation for research and treatment of cancer quality of life questionnaire core 30 (EORTC QLQ-C30 version 3.0), and the breast cancer-specific module (EORTC QLQ-BR23). All data will be collected by the same researcher. The primary hypothesis is that patients using the artificial intelligence-supported mobile application will demonstrate better symptom management, higher self-efficacy levels, and improved quality of life compared with patients receiving standard care alone. Findings from this study may contribute to the growing evidence regarding the integration of artificial intelligence and mobile health technologies into supportive cancer care and provide guidance for future digital health interventions targeting symptom management in breast cancer patients.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 70 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ege University is the lead sponsor of 377 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Breast cancer patients receiving first-time chemotherapy will use an AI-supported mobile application in addition to standard care. Participants will report daily symptoms through the application and receive personalized AI-generated symptom management recommendations and educational content.
Behavioral: AI-Supported Mobile Application
Participants will receive routine standard care provided by the chemotherapy centers without access to the mobile application.
Participants will use an AI-supported mobile application starting on the first day of chemotherapy. The application allows daily symptom reporting, provides AI-based personalized symptom management recommendations, and includes educational information about breast cancer and its treatment.
Symptom burden
Symptom burden will be assessed using the Memorial Symptom Assessment Scale (MSAS). The scale comprises a total of 32 symptoms, which are evaluated in terms of frequency, severity, and distress. On the Memorial Symptom Assessment Scale, each symptom is examined for presence or absence. If a symptom is present, it is rated as follows: for frequency: 1 (rarely), 2 (occasionally), 3 (frequently), 4 (almost constantly); for severity: 1 (mild), 2 (moderate), 3 (severe), 4 (very severe); for distress: 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Higher scores on the Memorial Symptom Assessment Scale indicate greater frequency, severity, and distress of the experienced symptoms.
Time frame: Baseline, after the end of Cycle 1 (each cycle is 21 days), and after the end of Cycle 4 (approximately up to 12 weeks)
Chemotherapy symptom management self-efficacy
Self-efficacy will be measured using the Chemotherapy Symptom Management Self-Efficacy Scale for Breast Cancer Patients. The scale consists of 27 items and three subdimensions. Each item is rated on a 0-10 Likert scale (0 = not confident at all, 10 = very confident). The total score ranges from 0 to 270. Higher scores indicate better self-efficacy (greater confidence in managing chemotherapy-related symptoms).
Time frame: Baseline, after the end of Cycle 1 (each cycle is 21 days), and after the end of Cycle 4 (approximately up to 12 weeks)
Quality of Life (EORTC QLQ-C30)
Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 Version 3.0). The scale contains 30 items assessing functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and global health status. All scores are transformed to a 0-100 range. Higher scores on global health status and functional scales indicate better quality of life, while higher scores on symptom scales indicate worse quality of life.
Time frame: Baseline, after the end of Cycle 1 (each cycle is 21 days), and after the end of Cycle 4 (approximately up to 12 weeks)
Quality of Life (EORTC QLQ-BR23)
Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 23 (EORTC QLQ-BR23). The scale contains 23 items assessing breast cancer-specific functional domains (body image, sexual functioning, sexual enjoyment, future perspective) and symptom domains (systemic therapy side effects, breast symptoms, arm symptoms, hair loss). All scores are transformed to a 0-100 range. Higher scores on functional scales indicate better quality of life, while higher scores on symptom scales indicate worse quality of life.
Time frame: Baseline, after the end of Cycle 1 (each cycle is 21 days), and after the end of Cycle 4 (approximately up to 12 weeks)
Plan to share: No — Individual participant data will not be shared because this study does not include a data-sharing plan approved by the ethics committee, and participants did not provide consent for public data sharing. To ensure confidentiality and protect participant privacy, de-identified individual-level data will remain with the research team only.
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