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

2026년 6월 11일 업데이트: 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).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

38

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
다른: Control Group
Participants will receive routine nursing care and standard patient education provided in the clinical setting.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Radiodermatitis Severity (Radiation Therapy Oncology Group Skin Toxicity Scale)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ataturk University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

  • 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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 7월 1일

연구 등록 날짜

최초 제출

2026년 6월 3일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ATA.2026.06

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Mozambique

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다