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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChung Shan Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Device

    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.

  • Enhanced Patient Education Materials (Behavioral/Educational Intervention)

    Behavioral

    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.

  • Internal Warning Signs and Alerts (Behavioral Intervention)

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intelligent Care System Group (Intervention Group)Experimental treatment 3 interventions
Group B: Standard Care Group (Control Group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Patient Anxiety Levels During Radiation Therapy

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.

Time frame
Baseline (before radiation therapy) and 3 weeks after treatment initiation
2

Treatment Adherence Rate During Radiation Therapy

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.

Time frame
Throughout the entire course of radiation therapy (typically 4-6 weeks)

Secondary outcomes

1

Change in Blood Cell Counts During Radiation Therapy

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.

Time frame
Weekly from baseline (Week 0) until treatment completion (approximately 4 to 6 weeks).
2

Patient Understanding of Self-Care and Blood Test Needs

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.

Time frame
Pre-treatment and after 3 weeks of treatment
3

Patient Satisfaction with the Intelligent Care System

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.

Time frame
At Week 6 (end of radiation therapy treatment, typically 4 to 6 weeks after initiation).

Other outcomes

Sponsors and contacts

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