Artificial Intelligence Powered Digital Education Based on the Neuman Systems Model for Breast Cancer Patients Receiving Radiotherap

NCT07649902 | Not Yet Recruiting

• 1 other identifier: ATA.2026.06
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical trial is to evaluate the effect of an artificial intelligence-supported digital education program developed based on the Neuman Systems Model on radiodermatitis severity and quality of life in women with breast cancer receiving radiotherapy. The intervention was developed based on the Neuman Systems Model, which served as the theoretical framework of the study. Educational content was structured according to the principles of the model and was designed to strengthen patients' flexible lines of defense, support resistance resources, facilitate adaptation to radiotherapy-related stressors, and promote system stability through primary, secondary, and tertiary prevention strategies. The study aims to answer the following questions:

• Is a Neuman Systems Model-based AI-supported digital education program effective in reducing the severity of radiotherapy-induced radiodermatitis?
• Is a Neuman Systems Model-based AI-supported digital education program effective in improving quality of life among women receiving radiotherapy for breast cancer? Participants assigned to the intervention group will be provided with access to the AI-supported digital education program developed in accordance with the Neuman Systems Model, whereas participants assigned to the control group will receive standard care. Differences between the groups with respect to radiodermatitis severity and quality of life outcomes will be evaluated. Participants will complete a Patient Information Form to collect sociodemographic and clinical characteristics prior to the initiation of radiotherapy. Radiodermatitis severity will be assessed using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Dermatitis Scale, and 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) and the breast cancer-specific module (EORTC QLQ-BR23). Following these assessments, participants will be randomly allocated to either the intervention group or the control group. Radiodermatitis severity will be evaluated weekly throughout the radiotherapy period using the RTOG scale and reassessed two weeks after completion of radiotherapy. Quality of life will be evaluated before radiotherapy and reassessed two weeks after completion of radiotherapy using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. Participants assigned to the intervention group will be provided with access to an AI-supported digital education platform incorporating educational modules, personalized educational recommendations, reminder notifications, and motivational messages. In addition, system usability will be evaluated at the end of the intervention period using the System Usability Scale (SUS).

Conditions

Breast Cancer; Radiodermatitis

Keywords

Breast Cancer; Radiotherapy; Radiodermatitis; Quality of Life; Artificial Intelligence; Digital Education; Neuman Systems Model; Nursing Intervention

Outcome Measures

Primary Outcomes (1)

• Radiodermatitis Severity (Radiation Therapy Oncology Group Skin Toxicity Scale)

  Radiodermatitis severity will be assessed using the Radiation Therapy Oncology Group (RTOG) Skin Toxicity Scale. The scale classifies acute radiation-induced skin reactions from Grade 0 (no skin reaction) to Grade 4 (ulceration, necrosis, or severe skin toxicity). Higher scores indicate more severe skin toxicity. Assessments will be performed weekly during radiotherapy and two weeks after completion of treatment by a trained clinical healthcare professional blinded to group allocation.

  Weekly during radiotherapy (5 weeks) and 2 weeks after completion of radiotherapy.

Secondary Outcomes (1)

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23

  Baseline and 2 weeks after completion of radiotherapy.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive access to an artificial intelligence-supported digital education program based on the Neuman Systems Model. Educational modules include radiotherapy information, recognition of radiodermatitis symptoms, preventive skin care practices, symptom management, psychological adaptation, and post-treatment care.

Behavioral: Neuman-Based AI-Supported Digital Education Program

Control Group

OTHER

Participants will receive routine nursing care and standard patient education provided in the clinical setting.

Other: Standard Care (in control arm)

Interventions

Neuman-Based AI-Supported Digital Education Program BEHAVIORAL

Participants assigned to the intervention group will receive access to an artificial intelligence-supported digital education program developed based on the Neuman Systems Model. The program consists of seven educational modules covering the radiotherapy process, recognition of early signs of radiodermatitis, preventive skin care practices, symptom management, psychological adaptation, social support, and post-treatment care. The system will analyze user engagement data, including platform usage frequency, module completion, viewing duration, and interaction patterns, to provide personalized educational recommendations. In addition, reminder notifications and motivational messages will be delivered to encourage adherence to the educational program and enhance participant engagement. Participants will have access to the digital education platform throughout the radiotherapy treatment period.

Intervention Group

Standard Care (in control arm) OTHER

Participants will receive routine nursing care and standard patient education provided in the radiotherapy clinic. Standard care includes verbal information and counseling regarding the radiotherapy process, skin care recommendations, symptom monitoring, and routine clinical follow-up.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older diagnosed with primary breast cancer who have completed surgical treatment and are scheduled to receive adjuvant radiotherapy.
• Patients who will receive radiotherapy for the first time.
• Patients whose general health condition is suitable for participation in the study and follow-up assessments.
• Patients who are able to read, understand, and communicate in Turkish.
• Patients who have access to the internet and are able to use a smartphone, tablet, or computer to access the digital education program.
• Patients who voluntarily agree to participate in the study and provide written informed consent.

You may not qualify if:

• Previous radiotherapy to the same treatment area.
• Presence of an active infection, open wound, or severe dermatological disease within the radiation treatment field.
• History of a chronic skin condition that may affect radiation-induced skin reactions.
• Cognitive or psychiatric conditions that may prevent participants from following the educational program or complying with the study procedures and data collection process.

Sponsors & Collaborators

• Ataturk University: lead

Related Publications (1)

• Mohamed, M., Khalaf, S., Khalaf, F., Mohamed, S. Education Program to Promote Skin Integrity and Reduce Pain for Patients Receiving External Beam Radiotherapy. Assiut Scientific Nursing Journal, 2022; 10(28): 191-199. DOI: 10.21608/ASNJ.2022.104791.1260

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Mehtap KAVURMACI

CONTACT

+90 442 231 3554; mehtap.kavurmaci@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiodermatitis severity will be assessed by a trained clinical healthcare professional who will be blinded to group allocation. The outcome assessor will not know whether participants are assigned to the intervention or control group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Doctoral Candidate, Department of Internal Medicine Nursing, Atatürk University

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share