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

Not Applicable

Not yet recruiting

• Conditions: Radiation Therapy; Chemoradiotherapy; Anxiety; Adherence

• Registration Number: NCT06833801
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-19
• Study Start: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Patient Anxiety Levels During Radiation Therapy	Baseline (before radiation therapy) and 3 weeks after treatment initiation	The study will measure changes in patient anxiety levels before and after the intervention using the Brief Symptom Rating Scale-5 (BSRS-5). The BSRS-5 is a validated psychological assessment tool designed to screen for psychological distress, including anxiety, depression, hostility, interpersonal sensitivity, and insomnia.; Scale Range: The BSRS-5 consists of five items, each scored from 0 (not at all) to 4 (extremely severe).; Minimum Score: 0 (indicating no psychological distress). Maximum Score: 20 (indicating severe psychological distress). Interpretation: Higher scores indicate worse psychological distress. Outcome Goal: A decrease in BSRS-5 scores in the intervention group compared to the control group will indicate reduced anxiety and improved psychological well-being.
Treatment Adherence Rate During Radiation Therapy	Throughout the entire course of radiation therapy (typically 4-6 weeks)	The study will track patient compliance with the prescribed radiation therapy regimen. Compliance will be measured through attendance records, completion of scheduled treatment sessions, and physician assessments. The intelligent care system is expected to improve adherence by increasing patient engagement and awareness through automated alerts and improved educational materials. A higher completion rate in the intervention group compared to the control group will indicate improved treatment adherence.

Secondary Outcome Measures

Name	Time	Method
Change in Blood Cell Counts During Radiation Therapy	Weekly from baseline (Week 0) until treatment completion (approximately 4 to 6 weeks).	This study will evaluate how often abnormal blood cell counts (White Blood Cell \[WBC\], Hemoglobin \[Hb\], and Platelet \[PLT\] levels) are detected and addressed using the real-time blood data monitoring system. The system provides timely alerts for abnormal values, enabling healthcare providers to intervene promptly.; Assessment Tool: Electronic medical records of routine blood test results. Outcome Goal: The intervention group is expected to have fewer missed abnormal results and faster clinical response times compared to the control group, indicating improved patient safety.
Patient Understanding of Self-Care and Blood Test Needs	Pre-treatment and after 3 weeks of treatment	Assess patient awareness and knowledge of self-care practices and the importance of blood test monitoring during radiation therapy. Patients will receive optimized educational materials, and their understanding will be evaluated through a self-reported questionnaire. A higher score in the intervention group compared to the control group will indicate improved patient education and awareness.
Patient Satisfaction with the Intelligent Care System	At Week 6 (end of radiation therapy treatment, typically 4 to 6 weeks after initiation).	Measure patient satisfaction regarding the new real-time blood monitoring alerts and enhanced educational materials provided as part of the intelligent care system. A patient-reported satisfaction survey will be conducted to evaluate the perceived usefulness and acceptability of the system.; Assessment Tool: Patient-reported satisfaction survey. Outcome Goal: Higher satisfaction scores in the intervention group compared to the control group, indicating greater patient acceptance and perceived benefits of the system.

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung City, Taiwan