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

11. juni 2026 oppdatert av: Kübra TEMÜR, Ataturk University

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.

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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

38

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention Group
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.
Atferdsmessig: Neuman-Based AI-Supported Digital Education Program
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.
Annen: Control Group
Participants will receive routine nursing care and standard patient education provided in the clinical setting.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Radiodermatitis Severity (Radiation Therapy Oncology Group Skin Toxicity Scale)
Tidsramme: 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.
Weekly during radiotherapy (5 weeks) and 2 weeks after completion of radiotherapy.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23
Tidsramme: Baseline and 2 weeks after completion of radiotherapy.

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
Baseline and 2 weeks after completion of radiotherapy.

Samarbeidspartnere og etterforskere

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Sponsor

Ataturk University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ATA.2026.06

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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