Breast CancerNCT07649902
Artificial Intelligence Powered Digital Education Based on the Neuman Systems Model for Breast Cancer Patients Receiving Radiotherap
A study testing Neuman-Based AI-Supported Digital Education Program in people with Breast Cancer and Radiodermatitis, run by Ataturk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiodermatitis
- What is being tested?
- Neuman-Based AI-Supported Digital Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Artificial Intelligence-Powered Digital Education Based on the Neuman Systems Model on Radiodermatitis Severity and Quality of Life in Breast Cancer Patients
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.
Read more
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
- Being tested
- Neuman-Based AI-Supported Digital Education Program, Standard Care (in control arm)
- Keywords
- Breast Cancer, Radiotherapy, Radiodermatitis, Quality of Life, Artificial Intelligence, Digital Education, Neuman Systems Model, Nursing Intervention
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuman-Based AI-Supported Digital Education ProgramBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Baseline and 2 weeks after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra TEMÜR, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649902
- Sponsor's protocol ID
- ATA.2026.06
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Artificial Intelligence-Powered Digital Education Based on the Neuman Systems Model on Radiodermatitis Severity and Quality of Life in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07649902
- Acronym / sponsor ID
- ATA.2026.06
- Conditions
- Breast Cancer, Radiodermatitis
- Keywords
- Breast Cancer, Radiotherapy, Radiodermatitis, Quality of Life, Artificial Intelligence, Digital Education, Neuman Systems Model, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Neuman-Based AI-Supported Digital Education ProgramParticipants 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. |
| Control Group | Other | Other: Standard Care (in control arm)Participants will receive routine nursing care and standard patient education provided in the clinical setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuman-Based AI-Supported Digital Education ProgramParticipants 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. | Behavioural | Intervention Group |
| Standard Care (in control arm)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. | Other | Control Group |
Primary outcome
Radiodermatitis Severity (Radiation Therapy Oncology Group Skin Toxicity Scale)
Time frame: Weekly during radiotherapy (5 weeks) and 2 weeks after completion of radiotherapy.
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.
1 secondary outcome
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23
Time frame: Baseline and 2 weeks after completion of radiotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- BackgroundMohamed, 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Neuman-Based AI-Supported Digital Education Program in people with Breast Cancer and Radiodermatitis, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehtap KAVURMACI (+90 442 231 3554 ext. 3554, mehtap.kavurmaci@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiodermatitis Severity (Radiation Therapy Oncology Group Skin Toxicity Scale) (time frame: Weekly during radiotherapy (5 weeks) and 2 weeks after completion of radiotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07649902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.