Artificial Intelligence-supported Mobile Application for Patients With Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEge University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18 years and older.
Diagnosed with breast cancer.
Patients with Stage 0, I, II, or III breast cancer.
Receiving chemotherapy for the first time.
Disqualifiers
Patients diagnosed with a primary cancer other than breast cancer.
Patients with severe comorbid diseases.
Patients receiving concurrent radiotherapy.
Patients diagnosed with inflammatory breast cancer.
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Supported Mobile Application
BehavioralParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: AI-Supported Mobile Application + Standard CareExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Ege University
Lead sponsor
Health Institutes of Turkey
Collaborator
Source ClinicalTrials.gov