Artificial Intelligence-supported Mobile Application for Patients With Breast Cancer

NCT07826338 | Recruiting DMC

• 2 other identifiers: 25-6T/6348671
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Chemotherapy Side Effects

Keywords

breast cancer; artificial intelligence; mobile health; Symptom Management; Self-Efficacy; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  Baseline, after the end of Cycle 1 (each cycle is 21 days), and after the end of Cycle 4 (approximately up to 12 weeks)

Study Arms (2)

AI-Supported Mobile Application + Standard Care

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Participants will receive routine standard care provided by the chemotherapy centers without access to the mobile application.

Interventions

AI-Supported Mobile Application BEHAVIORAL

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.

AI-Supported Mobile Application + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female patients are eligible for participation because the study population is limited to women diagnosed with breast cancer and receiving chemotherapy, as specified in the study protocol and ethics committee approval.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Ege University Hospital, Berna Türek Chemotherapy Center

Izmir, İzmir, 35100+, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Fjell 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 BACKGROUND

• Grasic 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 BACKGROUND

• Baik 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 BACKGROUND

• Jiang 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 BACKGROUND

• Seven 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 BACKGROUND

• El-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 BACKGROUND

• 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.

  PMID: 38969573 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yasemin Yıldırım, Prof. Dr.

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gökhan Sezgin, PhD Candidate

CONTACT

+00905363005966; gokhan.sezgin95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Nurse

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: September 17, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)