Not Yet RecruitingNot Applicable

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

38 participantsStarted 2026-08-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiodermatitis Severity (Radiation Therapy Oncology Group Skin Toxicity Scale)

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

Trial details

NCT IDNCT07649902

SponsorAtaturk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Mehtap KAVURMACI

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

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