Application of Intelligent Care Systems in Radiation Therapy: Enhancing Patient Safety and Reducing Anxiety Through System Optimization and Real-Time Blood Data Monitoring

Official title

Application of Intelligent Care Systems in Radiation Therapy: Enhancing Patient Safety and Reducing Anxiety Through System Optimization, Enhanced Education Strategies, and Real-Time Blood Data Monitoring

Overview

This study aims to evaluate the impact of an intelligent care system on radiation therapy patients, focusing on real-time blood data monitoring, optimized patient education, and internal alert systems. The goal is to enhance patient safety, improve treatment adherence, and reduce anxiety by integrating an alert function into the hospital's existing system. Key interventions include: Real-time blood monitoring alerts: Healthcare providers will receive automatic notifications of abnormal blood test results to ensure timely intervention. Optimized patient education materials: Clearer guidance will help patients proactively communicate blood test needs and manage their health during radiation therapy. Internal reminders: Visual signs and alerts in treatment areas will reinforce patient awareness and engagement. The study will compare patients receiving these interventions with those under standard care, assessing treatment compliance, anxiety levels, and clinical outcomes over a 12-month period.

Detailed description

Background \& Rationale Cancer patients undergoing radiation therapy often experience changes in blood cell counts, particularly when combined with chemotherapy, affecting treatment safety and completion rates. Lack of real-time monitoring and patient engagement can lead to delays or complications in treatment. This study integrates an intelligent care system into clinical practice to enhance patient monitoring and education, reducing treatment interruptions and improving outcomes.

Study Objectives

System Optimization: Develop an automated blood data monitoring system that alerts medical staff and patients about abnormal results.

Patient Education Enhancement: Improve educational materials to guide patients on self-care and timely communication with healthcare providers.

Internal Warning Implementation: Install reminder signs in treatment areas to increase awareness and compliance.

Study Design

Type: Interventional (Clinical Trial) Design: Randomized, parallel assignment

Groups:

Intervention Group: Receives real-time monitoring alerts, enhanced education materials, and internal warning systems.

Control Group: Receives standard care without system enhancements. Primary Outcomes: Anxiety reduction (measured by BSRS-5) and treatment adherence rates.

Secondary Outcomes: Blood data changes, patient understanding of self-care, and clinical treatment outcomes.

Expected Impact By combining real-time data monitoring with patient education and engagement, this study aims to create a safer, more informed treatment experience, reducing patient anxiety and enhancing overall treatment success.

Interventions

• Device Real-Time Blood Data Monitoring System (Device/Software Integration)
  Description: An alert function will be integrated into the hospital's electronic system, allowing healthcare providers to view real-time blood test results of radiation therapy patients. The system will notify both medical staff and patients of abnormal results, prompting timely intervention. Mode of Delivery: Hospital Information System (HIS) Integration Purpose: Improve treatment safety by reducing delays in managing abnormal blood counts.
• Behavioral Enhanced Patient Education Materials (Behavioral/Educational Intervention)
  Description: Optimized educational pamphlets and multimedia resources will be provided to patients, including clear self-care instructions and guidance on reporting blood test needs during radiation therapy. Mode of Delivery: Printed materials, multimedia resources, verbal education by medical staff Purpose: Improve patient understanding and engagement in their treatment process.
• Behavioral Internal Warning Signs and Alerts (Behavioral Intervention)
  Description: Physical reminder signs will be placed in high-traffic patient areas (e.g., check-in counters, treatment rooms) to prompt patients to report discomfort or abnormal symptoms, especially related to blood test needs. Mode of Delivery: Visual reminders placed within the radiation oncology department Purpose: Increase patient awareness and adherence to treatment safety protocols.

Primary outcome measures

• Change in Patient Anxiety Levels During Radiation Therapy [Time frame: Baseline (before radiation therapy) and 3 weeks after treatment initiation]
• Treatment Adherence Rate During Radiation Therapy [Time frame: Throughout the entire course of radiation therapy (typically 4-6 weeks)]

Secondary outcome measures (3)

• Change in Blood Cell Counts During Radiation Therapy [Time frame: Weekly from baseline (Week 0) until treatment completion (approximately 4 to 6 weeks).]
• Patient Understanding of Self-Care and Blood Test Needs [Time frame: Pre-treatment and after 3 weeks of treatment]
• Patient Satisfaction with the Intelligent Care System [Time frame: At Week 6 (end of radiation therapy treatment, typically 4 to 6 weeks after initiation).]

Eligibility criteria

Inclusion criteria

• Patients undergoing radiation therapy combined with chemotherapy.
• Age ≥ 18 years.
• Ability to understand and comply with the study protocol.
• Willing to participate in the study and provide informed consent.

Exclusion criteria

• Patients with severe cognitive impairment or intellectual disability, affecting their ability to understand or follow study procedures.
• Patients unwilling to complete study questionnaires.
• Any mental health condition (e.g., major depressive disorder, severe anxiety disorder) that could interfere with participation.
• Patients with conditions requiring immediate intervention that would make study participation impractical.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Taiwan · 1 center

• Chung Shan Medical University — Taichung

Identifiers

NCT: NCT06833801 · 2025-A-031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗