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)

February 18, 2025 updated by: Chung Shan Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung City, Taiwan, 403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intelligent Care System Group (Intervention Group)
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.
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.
No Intervention: Standard Care Group (Control Group)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Anxiety Levels During Radiation Therapy
Time Frame: 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.
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)
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.
Throughout the entire course of radiation therapy (typically 4-6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Cell Counts During Radiation Therapy
Time Frame: 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.
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
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.
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).

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A-031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Real-Time Blood Data Monitoring System (Device/Software Integration)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe