Clinical trial · Interventional
Artificial Intelligence-supported Mobile Application for Patients With Breast Cancer
Effects of an Artificial Intelligence-supported Mobile Application on Symptom Management, Self-efficacy, and Quality of Life in Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Side Effects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-Supported Mobile Application | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AI-Supported Mobile Application + Standard Care
- description
- 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.
- interventionNames
- Behavioral: AI-Supported Mobile Application
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- Participants will receive routine standard care provided by the chemotherapy centers without access to the mobile application.
Primary outcomes (4)
- measure
- Symptom burden
- timeFrame
- Baseline, after the end of Cycle 1 (each cycle is 21 days), and after the end of Cycle 4 (approximately up to 12 weeks)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * In a stable physical and psychological condition that does not interfere with participation in the study. * Able to read and write in Turkish. * Own a smartphone and have sufficient technological skills to use the mobile application. * Willing to participate in the study and able to provide written informed consent. Exclusion Criteria: * 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. * Patients using luteinizing hormone-releasing hormone (LHRH) analogs. * Patients with severe cognitive impairment or psychiatric disorders. * Patients who do not have access to a mobile device or internet connection. * Patients who do not have the skills necessary to use the mobile application.
References
Publications (7)
- BACKGROUNDFjell M, Langius-Eklof A, Nilsson M, Wengstrom Y, Sundberg K. Reduced symptom burden with the support of an interactive app during neoadjuvant chemotherapy for breast cancer - A randomized controlled trial. Breast. 2020 Jun;51:85-93. doi: 10.1016/j.breast.2020.03.004. Epub 2020 Mar 20. PMID 32247251
- BACKGROUNDGrasic Kuhar C, Gortnar Cepeda T, Kovac T, Kukar M, Ruzic Gorenjec N. Mobile App for Symptom Management and Associated Quality of Life During Systemic Treatment in Early Stage Breast Cancer: Nonrandomized Controlled Prospective Cohort Study. JMIR Mhealth Uhealth. 2020 Aug 4;8(8):e17408. doi: 10.2196/17408. PMID 32427567
- BACKGROUNDBaik SH, Oswald LB, Buitrago D, Buscemi J, Iacobelli F, Perez-Tamayo A, Guitelman J, Diaz A, Penedo FJ, Yanez B. Cancer-Relevant Self-Efficacy Is Related to Better Health-Related Quality of Life and Lower Cancer-Specific Distress and Symptom Burden Among Latina Breast Cancer Survivors. Int J Behav Med. 2020 Aug;27(4):357-365. doi: 10.1007/s12529-020-09890-9. PMID 32394220
- BACKGROUNDJiang L, Xu J, Wu Y, Liu Y, Wang X, Hu Y. Effects of the "AI-TA" Mobile App With Intelligent Design on Psychological and Related Symptoms of Young Survivors of Breast Cancer: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jun 4;12:e50783. doi: 10.2196/50783. PMID 38833298
- BACKGROUNDSeven M, Pasalak S, Bagcivan G, Ozkasap O, Selcukbirick F. A Mobile Application for Symptom Management in Patients With Breast Cancer. Oncol Nurs Forum. 2022 Aug 18;49(5):409-420. doi: 10.1188/22.ONF.409-420. PMID 36067241
- BACKGROUNDEl-Amir A, El-Baiomy EM, Sabry NA, Kassem L, Chesney MA, Wallston KA. The relationship between coping self-efficacy and B cells in breast cancer patients. J Egypt Natl Canc Inst. 2023 Sep 4;35(1):28. doi: 10.1186/s43046-023-00187-y. PMID 37661196
- Balci H, Faydali S. The Effect of Education Performed Using Mobile Application on Supportive Care Needs and Quality of Life in Women with Breast Cancer: Randomized Controlled Trial. Semin Oncol Nurs. 2024 Aug;40(4):151684. doi: 10.1016/j.soncn.2024.151684. Epub 2024 Jul 4.