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

Chung Shan Medical University

Status: Not yet enrolling

Conditions: Radiation Therapy; Adherence; Chemoradiotherapy; Anxiety

Treatments: Behavioral: Enhanced Patient Education Materials (Behavioral/Educational Intervention); Behavioral: Internal Warning Signs and Alerts (Behavioral Intervention); Device: Real-Time Blood Data Monitoring System (Device/Software Integration)

Study type: Interventional

Funder types: Other

Identifiers

NCT06833801

2025-A-031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intelligent Care System Group (Intervention Group)

Experimental group

Description:

Participants in this group will receive an optimized intelligent care system designed to enhance patient safety, improve treatment adherence, and reduce anxiety during radiation therapy. This system includes real-time blood data monitoring alerts, enhanced patient education materials, and internal warning reminders.

Treatment:

Device: Real-Time Blood Data Monitoring System (Device/Software Integration)

Behavioral: Internal Warning Signs and Alerts (Behavioral Intervention)

Behavioral: Enhanced Patient Education Materials (Behavioral/Educational Intervention)

Standard Care Group (Control Group)

No Intervention group

Description:

Participants in this group will receive standard care without the optimized intelligent care system interventions. They will continue their treatment following existing clinical practices without additional automated monitoring or enhanced education strategies.