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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Group | Other | Participants will receive routine nursing care and standard patient education provided in the clinical setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23 | The Breast Cancer module is a supplementary questionnaire module to be employed in conjunction with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire- C30. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module- BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. The scoring approach for Breast Cancer Module is identical in principle to that for the function and symptom scales / single items of the QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehtap KAVURMACI | Contact | +90 442 231 3554 | 3554 | mehtap.kavurmaci@atauni.edu.tr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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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.
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| 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. |
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| Baseline and 2 weeks after completion of radiotherapy. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003872 | Dermatitis |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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